Human milk banking services: An umbrella review protocol

Roisin O'Donovan; Aoife Long; Elaine Lehane; Helen Mulcahy; Siobhan Ward; Margaret Murphy; Susan Rogers; Gillian Weaver; Patricia Leahy-Warren

doi:10.12688/hrbopenres.14180.2

Home Browse Human milk banking services: An umbrella review protocol

ALL Metrics

Views

Downloads

Get PDF

Get XML

Export

▬

✚

Study Protocol

Revised

Human milk banking services: An umbrella review protocol

[version 2; peer review: 1 approved]

Roisin O'Donovan ¹, Aoife Long¹, Elaine Lehane¹, [...] Helen Mulcahy¹, Siobhan Ward², Margaret Murphy¹, Susan Rogers³, Gillian Weaver⁴, Patricia Leahy-Warren¹

Roisin O'Donovan ¹, Aoife Long¹, [...] Elaine Lehane¹, Helen Mulcahy¹, Siobhan Ward², Margaret Murphy¹, Susan Rogers³, Gillian Weaver⁴, Patricia Leahy-Warren¹

PUBLISHED 28 Aug 2025

Author details Author details

¹ University College Cork School of Nursing and Midwifery, Cork, County Cork, Ireland
² La Leche League International, Dublin, Ireland
³ Western Health & Social Care Trust, Londonderry, UK
⁴ Human Milk Foundation, Hertfordshire, UK

Roisin O'Donovan
Roles: Conceptualization, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Aoife Long
Roles: Conceptualization, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Elaine Lehane
Roles: Conceptualization, Investigation, Methodology, Project Administration, Supervision, Writing – Review & Editing

Helen Mulcahy
Roles: Investigation, Methodology, Supervision, Writing – Review & Editing

Siobhan Ward
Roles: Writing – Review & Editing

Margaret Murphy
Roles: Writing – Review & Editing

Susan Rogers
Roles: Writing – Review & Editing

Gillian Weaver
Roles: Conceptualization, Supervision, Writing – Review & Editing

Patricia Leahy-Warren
Roles: Conceptualization, Methodology, Project Administration, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Objective

To review the current state of the art of human milk banking including evidence on development and implementation of human milk banking services in middle- and high-income countries; models of delivery; and the roles of key stakeholders in supporting and sustaining human milk banking services.

Introduction

Donor Human Milk (DHM) is human milk in excess of an infant's current and future needs that is donated for use by another infant. The World Health Organisation recommends that it should be available to all preterm and low birthweight infants. Human Milk Banks (HMB) require operational sustainability to ensure all year-round consistency and equity of DHM supply. This review will inform the co-design of an evidence framework for a national human milk banking resource network.

Inclusion criteria

Systematic reviews of studies reporting on the development, implementation and sustainability of a milk banking service in middle- and high-income countries.

Methods

The guidelines for umbrella reviews from the JBI Manual for Evidence Synthesis will be followed. A key word search strategy will be used to search: CINAHL (EBSCO), MEDLINE (EBSCO), PsycINFO (EBSCO), Embase (Ovid), JBI Evidence Synthesis, Epistemonikos, and the PROSPERO register. A grey literature search will be undertaken on Google scholar, BASE and the National Institute for Health and Care Excellence (NICE) website. English language and date restrictions (2000-current) will be used. Titles and abstracts and full-text articles will be independently screened by two reviewers. The reference lists of the included studies will be searched. Studies will be screened in Covidence by two independent reviewers. All reviewers will agree on the included studies. Data will be extracted and presented graphically using figures and tables. Narrative summary text will accompany the tables and figures.

This protocol has been registered on PROSPERO

Keywords

Human milk banking; Umbrella Review

Corresponding author: Roisin O'Donovan

Competing interests: Gillian Weaver has no commercial or corporate conflicts of interest in this area. However, she would like to declare her role as co-founder of a non profit human milk bank- Human Milk Foundation. All other authors have no conflict of interest to declare.

Grant information: Health Research Board -APRO-2023-015
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 O'Donovan R et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: O'Donovan R, Long A, Lehane E et al. Human milk banking services: An umbrella review protocol [version 2; peer review: 1 approved]. HRB Open Res 2025, 8:69 (https://doi.org/10.12688/hrbopenres.14180.2) First published: 19 Jun 2025, 8:69 (https://doi.org/10.12688/hrbopenres.14180.1) Latest published: 28 Aug 2025, 8:69 (https://doi.org/10.12688/hrbopenres.14180.2)

Revised Amendments from Version 1

This version has been updated based on feedback and suggestions made by Reviewer 1.
1) We have kept our original search strategy as scoping searches found they appeared in some relevant titles.
2) We have now specified that the depth of screening for Google Scholar was the first 100 results, sorted by relevance. All identified items were screening for the other databases.
3) We have added “review type” to Table 4. However, once we completed screening for this review, it was clear that it would not be possible to filter reviews by country. Identified reviews included studies conducted in both high and low-and-middle-income countries or did not clearly report the countries for individual studies. Considering the goal of an Umbrella Review is to summarize or synthesize the findings of systematic reviews, and not individual studies, we did not exclude studies or findings from lower-income countries. Therefore, our results are not restricted to middle- and high income countries, as originally planned in our study protocol.
Minor issues:
We have now corrected typos in the updated version of our protocol.

See the authors' detailed response to the review by Tengfei Li

Introduction

The World Health Organisation (WHO) recommends that Donor Human Milk (DHM) should be available to all preterm and low birthweight infants. DHM is human milk in excess of an infant's current and future needs that is donated for use by another infant (PATH, 2019b). In the absence of any or insufficient Mothers Own Milk (MOM), DHM, obtained from a Human Milk Bank (HMB) facility, is recommended for the care of preterm or low birthweight infants (World Health Organization, 2011; World Health Organization, 2022). When supplementation is required, DHM should be used as an alternative to formula and serve as a bridge to ensure an exclusively human milk diet through providing lactation support to build mothers milk supply (PATH, 2019b) or, where needed, as an infant’s sole source of human milk.

Human milk is recognised as a pillar of child survival globally (Victora et al., 2016) and is the optimal diet for preterm infants (Cleminson et al., 2016). It provides a host of nutritional, immunological, neurological and physiological benefits to infants (Israel-Ballard et al., 2024; Ong & Belfort, 2021). An exclusively human milk diet during the first days of life is associated with decreased infection, morbidity, and mortality in very low birth weight infants (Corpeleijn et al., 2012; Lapidaire et al., 2022; Lucas & Cole, 1990; Meinzen-Derr et al., 2009; Sisk et al., 2007). Preterm infants who are exclusively fed human milk are less likely to suffer from necrotising enterocolitis compared to formula fed infants (Lucas & Cole, 1990; Quigley et al., 2024; Sisk et al., 2007). However, preterm and low birth weight infants often do not have access to their own mother’s milk in the first hours or days, weeks or even months of their life (Israel-Ballard et al., 2024; Tudehope, 2013). Women who deliver babies preterm can encounter a variety of challenges that lead to low rates of breastfeeding. They are often separated from their infants at birth and must learn how to establish and maintain milk production by expression. This requires support both in the hospital and after they are discharged to achieve and sustain exclusive breastfeeding (Israel-Ballard et al., 2024; Tudehope, 2013). Providing access to DHM for preterm or low birthweight infants can provide them with an optimal 100% human milk diet while their mother establishes her own milk supply.

There are currently approximately 800 Human Milk Banks (HMB) operating globally in approximately 70 countries (Human Milk Bank Global Map, 2019). HMBs require operational sustainability to ensure all year-round consistency and equity of DHM supply. The sustainability of HMB depends on DHM supply and demand, financial sustainability, and communications, policy and advocacy to support HMB (Israel-Ballard et al., 2024). Sustainability measures that support supply and demand for a HMB include providing lactation support for mothers to maintain a donor pool, securing engagement of local stakeholders and maintaining sound financial and business practices (Israel-Ballard et al., 2024; PATH, 2019a). Community education and engagement can raise public awareness of HMB activities and normalise human milk feeding for all infants (Israel-Ballard et al., 2024). HMB services that exist within a supportive health care system, alongside governmental support, and national advertising campaigns can support awareness and the ongoing need for donors (Herson & Weaver, 2024).

Ensuring sustainable service provision requires equitable recruitment of donors and equitable clinical provision of donor milk. Lack of equal opportunity to donate milk and access DHM exist at national and regional levels globally (Herson & Weaver, 2024; Israel-Ballard et al., 2024). Providing payments or reimbursements to milk providers is not the norm and is illegal in a few countries, however, informal channels (i.e. the internet) mean that it is often tolerated in other countries (Herson & Weaver, 2024; Klotz et al., 2022). The absence of financial or other incentives minimises the chance of donors deliberately concealing information that may impact the quality and safety of their milk (i.e. drug, tobacco and alcohol use). Providing adequate support and accurate information to enable informed consent is vital to avoid exploitation of human milk donors and their infants (Herson & Weaver, 2024). DHM is typically allocated based on the risk of morbidity and mortality, prioritising the smallest and sickest infants to avoid the potential health risks associated with formula use (Israel-Ballard et al., 2024).

HMB should champion breastfeeding within their community and support lactation and continued breastfeeding while collecting, processing and distributing safe and high-quality DHM (Herson & Weaver, 2024; Israel-Ballard et al., 2024). It is important that DHM and HMB are integrated with the provision of comprehensive support for and promotion of exclusive breastfeeding. This involves providing lactation support services such as peer support groups, maternal health services referrals, and expression equipment. Supporting maternal lactation and breastfeeding also includes reducing the need for supplementary nutrition through avoiding separation of mother and child, promoting skin- to-skin care, and following the United Nations International Children's Emergency Fund Baby Friendly Initiative recommendations for providing practical lactation and breastfeeding support (Herson & Weaver, 2024). Providing this maternal lactation and breastfeeding support ensures the sustainability of DHM supply and demand (Israel-Ballard et al., 2024).

Resources for establishing and integrating human milk banks are openly available online, including a toolkit to guide critical steps for establishing human milk banking as an integrated component within breastfeeding support and neonatal care (PATH, 2025). These resources provide in-depth guidance on readiness, quality assurance, operations, auditing, training, monitoring and evaluation, and communications. In May 2024, the EU Council has adopted new rules aimed at improving the safety and quality of substances of human origin (SoHO). Building on this, the IMAGINE-HMB Project is an EU-funded initiative which aims to develop evidence-based guidelines that are aligned to the EU SoHO regulation and ensure the safety and quality of donor human milk (DHM). This project will assemble a multidisciplinary forum of experts to develop and launch a comprehensive plan to assist human milk banks in complying with technical and oversight standards, making the new guidelines accessible and actionable across diverse settings. In preparation for these projects, many systematic and scoping reviews have been conducted over the past 15–20 years.

This umbrella review aims to synthesize evidence from systematic reviews in order to understand how human milk bank services have been developed and scaled at the national level in middle- and high-income countries. It will inform the co-design of an evidence framework cognisant of governance, quality and sustainability criteria for a proposed national milk banking resource network.

A preliminary search for existing Umbrella Reviews on milk banking services was conducted using the Epistomonikos and PROSPERO databases and none were found.

Objective

The key objectives of this review are:

To understand how human milk banks are defined in the literature.
To identify how human milk banks have been funded, developed and scaled at the national level in middle- and high-income countries.
To identify and compare organizational models (e.g., centralized, regionalized, decentralized, or federalized systems) used in the implementation of human milk banks.
To understand the distribution/access models used for DHM and how they are impacted by DHM supply, including available guidelines and decision making of clinical staff.
To explore the roles of key stakeholders (e.g., government agencies, hospitals, professional associations, donors and recipients) in supporting and sustaining milk bank networks.
To examine common facilitators and barriers to the implementation of milk banks in diverse middle- and high-income contexts.

Research questions

The overarching research question for this review is: What is the current state of the art in the development and national-level implementation of human milk bank service, including operational models, implementation, and integration into healthcare systems?

The specific research questions are:

How have human milk banks been defined in the literature?
How have human milk bank networks been funded, developed and scaled at the national level in middle- and high-income countries?
What are the organizational models (e.g., centralized, regionalized, decentralized or federalized systems) used in the implementation of milk banks?
What distribution/access models have been used for DHM and how are they impacted by DHM supply, available guidelines and decision making of clinical staff?
What roles do key stakeholders (e.g., government agencies, hospitals, professional associations, donors and recipients) play in supporting and sustaining milk bank networks?
What are the facilitators and barriers to the implementation of milk banks in diverse middle- and high-income contexts?

Methods and analysis

Design

This review will follow the guidelines for umbrella reviews from the JBI Manual for Evidence Synthesis (Aromataris & Munn, 2020). An umbrella review is a systematic review of existing systematic reviews (Aromataris et al., 2024). Given the large number of systematic reviews that are available, umbrella reviews are conducted to compare and contrast these published reviews (Aromataris et al., 2024). Umbrella reviews allow researchers to address a broad scope of issues related to a topic of interest- this umbrella review will provide an overall examination of a body of information available on developing and implementing a HMB in middle- or high-income countries. This will provide an exploration of the approaches taken internationally to inform the acceptability, development, implementation, and maintenance model of a national HMB.

Inclusion criteria

Systematic reviews of studies reporting on the development and implementation of a milk banking service in middle and high income countries. Reviews published in English since 2000 will be considered for inclusion. For the purposes of an Umbrella Review, the term “studies” will refer exclusively to syntheses of research evidence including systematic reviews and meta-analyses.

Participants

Prospective, current or past human milk donors; donor milk recipient families; staff working within HMB service.

Phenomena of interest

This review is focused on HMB service and the provision of donor human milk.

Outcomes

The acceptability, development, implementation, and maintenance of affordable, effective, efficient, safe and sustainable HMB service.

Context/Setting

Human milk banks or HMB service operating in any middle- and high-income country.

Types of studies

Existing systematic reviews and meta-analyses. All types of syntheses of research evidence will be included, including systematic reviews in their various forms (effectiveness, meta-aggregative, integrative, meta-synthesis etc.) and meta-analyses.

Exclusion criteria

Reviews that do not report on the development or implementation of a human milk bank service. Reviews not available in English. Reviews that do not focus on middle- and high-income countries.

Search strategy

A three- phase search process will be used to locate both published and unpublished reviews (Aromataris et al., 2024). An initial search was carried out on PubMed and CINAHL and Medline to identify articles on the topic. The initial keywords are informed by the Special Issue of Maternal and Child Nutrition Volume 20: Expert overview of critical focus areas towards the development of global human milk bank standards from July 2024.

The keywords contained in the Special Issue were used to develop a full search strategy (Table 1 and Table 2). The search strategy was reviewed by topic experts and knowledge users who are professionals in this are.

Table 1. Developing the Search Strategy.

Search concepts	Human Milk Bank Service	Synthesis studies
Search terms	“donor milk” OR “milk bank” OR “milkbank” OR “human milk bank” OR “donor human milk” OR “milk donation” OR “donor breastmilk” OR “donor breast milk” OR “human donor milk” OR “human milk donor” OR “Breast milk bank” OR "human milk shar" OR "milk shar" OR "milk kinship" OR "nurs milk" OR "cross* milk" OR "milk sibling*"	“systematic” OR “meta- analysis” OR “meta-aggregative” “integrative review” OR “meta-synthesis”

Table 2. Search Strategy.

Search	Query
#1	Title/Abstract: “donor milk” OR “milk bank” OR “milkbank” OR “human milk bank” OR “donor human milk” OR “milk donation” OR “donor breastmilk” OR “donor breast milk” OR “human donor milk” OR “human milk donor” OR “Breast milk bank” OR "human milk shar" OR "milk shar" OR "milk kinship" OR "nurs milk" OR "cross* milk" OR "milk sibling*"
#2	Title/Abstract: “systematic” OR “meta- analysis” OR “meta-aggregative” “integrative review” OR “meta-synthesis”
#3	#1 AND #2
Limits	2000-present

Database-specific searches will be conducted for CINAHL (EBSCO), MEDLINE (EBSCO), PsycINFO (EBSCO), PubMed, and Embase (Ovid). Major repositories of systematic reviews will also be searched, namely JBI Evidence Synthesis, Epistemonikos, and the PROSPERO register. A grey literature search will be undertaken on Google scholar, BASE and the National Institute for Health and Care Excellence (NICE) website. The first 100 items, sorted by relevance, on Google scholar will be screened. All items from other databases will be screened. The reference list of all included reviews will be searched. Date restrictions (2000-current) will be used. One full search has been included in this protocol (Table 3).

Table 3. Full Sample Search String for CINAHL.

Search	Query	Records Retrieved
#1	Title/Abstract: (MH "Donor Milk") OR (MH "Milk Banks") OR “milkbank” OR “human milk bank” OR “donor human milk” OR “milk donat” OR “donor breastmilk” OR “donor breast milk” OR “human donor milk” OR “human milk donor” OR “Breast milk bank” OR "human milk shar" OR "milk shar" OR "milk kinship" OR "nurs milk" OR "cross* milk" OR "milk sibling*"	1,222
#2	Title/Abstract: (MM "Systematic Review") OR "systematic" OR (MM "Meta Analysis") OR "Meta- analysis" OR "meta analysis" OR “meta-aggregative” “integrative” OR “meta-synthesis”	269,543
#3	#1 AND #2	48
Limits	2000-present

Screening

All identified articles will be uploaded to Covidence. Duplicates will be removed. Title and abstracts of the remaining articles will be screened by two independent reviewers. The full text of all articles that meet the inclusion criteria will then be reviewed and screened by two independent reviewers on Covidence. If there are any disagreements between reviewers during the screening process, a third reviewer will assess the relevant records, and consensus will be reached on eligibility through discussion. Reasons for article exclusion will be reported. Results of the screening process will be presented in a PRISMA flow diagram (Tricco et al., 2018).

Data extraction

Two independent reviewers will conduct data extraction. A data extraction template based on the standardised JBI data extraction tools will be used. This template will be adapted to align with the review objectives and research questions (Table 4). It will be piloted and revised, if needed, before use. The following categories will be included in the data extraction tool; author, year, country, type of evidence source, study aim and objectives, participants, context, HMB service type, approach to HMB service development, HMB service organisational model, role of key stakeholders, implementation facilitators and barriers. Any disagreements between reviewers will be resolved through discussion or with a third reviewer. If necessary, authors of papers will be contacted to request missing or additional information.

Table 4. Data Extraction Instrument.

Author/
Year/Review Type

Objectives

Participants
(characteristics/
total number)

Setting/
context

Search
details
(sources
searched/
date range/
number
studies
included)

Study
appraisal
rating

HMB
service
type/model-
including
distribution/
access
models

Role of key
stakeholders
–
Governance
and
Personnel?

Development/
Implementation
process,
facilitators and
barriers

Funding
source/
type

Factors
impacting
Sustainability
(including
acceptability)
and
Maintenance
of HMB

Donor
Experience

Data analysis

All extracted data will be mapped and summarised according to the aims and objectives of this review. All included systematic reviews will be summarised based on the studies’ characteristics, including the year, study aim and objectives, participants, context and HMB characteristics.

Narrative summaries will outline characteristics of HMBs, including organizational models used; roles of key stakeholders; facilitators and barriers to development and implementation. This information will be analysed to build our understanding of the current state of the art in human milk banking services. Data will be presented graphically using figures and tables which will be accompanies by narrative summaries to explain the results presented.

We will adopt a reflexive approach throughout the review process. This will involve reviewers engaging in critical reflection throughout all the stages outlines above, namely study screening, data extraction, and interpretation of the finding. They will be conscious of the potential biases inherent in the synthesis process and will disclose their perspectives, decisions made during the review process, and how these may influence findings in the final report where relevant. These processes will be reported in a reflexive statement to provide a richer understanding of the decisions and interpretation that influenced the review findings.

Quality assessment

The JBI critical appraisal instrument for Systematic reviews and Research Syntheses will be used to assess the quality of all included studies.

Data summary

A narrative synthesis will be presented to summarise the range of over-arching structures, processes and approaches employed internationally to support the development and implementation of a HMB service. The results of the review will inform the co-design of a framework for a national human milk bank service. Any overlaps of original research studies in each of the included research syntheses will be clearly indicated in the review findings.

Ethics and consent

Ethics and consent were not required

Data availability statement

PRISMA-P Checklist: Available on Zenodo under CC0 license. DOI. https://doi.org/10.5281/zenodo.15624176 (O’Donovan, 2025)

No other data are associated with this article.

Faculty Opinions recommended

References

Aromataris E, Fernandez R, Godfrey C, et al.: Umbrella reviews. In: JBI Manual for Evidence Synthesis. JBI, 2024. Publisher Full Text
Aromataris E, Munn Z, eds.: JBI manual for evidence synthesis. JBI, 2020.
Cleminson JS, Zalewski SP, Embleton ND: Nutrition in the preterm infant: what’s new? Curr Opin Clin Nutr Metab Care. 2016; 19(3): 220–225. PubMed Abstract
Corpeleijn WE, Kouwenhoven SMP, Paap MC, et al.: Intake of own mother’s milk during the first days of life is associated with decreased morbidity and mortality in very low birth weight infants during the first 60 days of life. Neonatology. 2012; 102(4): 276–281. PubMed Abstract | Publisher Full Text
Herson M, Weaver G: A comparative review of human milk banking and national tissue banking programs. Matern Child Nutr. 2024; 20 Suppl 4(Suppl 4): e13584. PubMed Abstract | Publisher Full Text | Free Full Text
Human Milk Bank Global Map: Human milk bank global map tableau. 2019. Reference Source
Israel‐Ballard K, LaRose E, Mansen K: The global status of human milk banking. Matern Child Nutr. 2024; 20 Suppl 4(Suppl 4): e13592. PubMed Abstract | Publisher Full Text | Free Full Text
Klotz D, Wesołowska A, Bertino E, et al.: The legislative framework of donor human milk and human milk banking in Europe. Matern Child Nutr. 2022; 18(2): e13310. PubMed Abstract | Publisher Full Text | Free Full Text
Lapidaire W, Lucas A, Clayden JD, et al.: Human milk feeding and cognitive outcome in preterm infants: the role of infection and NEC reduction. Pediatr Res. 2022; 91(5): 1207–1214. PubMed Abstract | Publisher Full Text | Free Full Text
Lucas A, Cole TJ: Breast milk and neonatal necrotising enterocolitis. Lancet. 1990; 336(8730–8731): 1519–1523. PubMed Abstract | Publisher Full Text
Meinzen-Derr J, Poindexter B, Wrage L, et al.: Role of human milk in extremely low birth weight infants’ risk of necrotizing enterocolitis or death. J Perinatol. 2009; 29(1): 57–62. PubMed Abstract | Publisher Full Text | Free Full Text
Ong ML, Belfort MB: Preterm infant nutrition and growth with a human milk diet. Semin Perinatol. 2021; 45(2): 151383. PubMed Abstract | Publisher Full Text
O'Donovan R: HMB_Umbrella_Protocol_PRISMA-P-SystRev-checklist. Zenodo. 2025. http://www.doi.org/10.5281/zenodo.15624176
PATH: Strengthening human milk banking: a resource toolkit for establishing & integrating human milk bank programs—a global implementation framework. 2019a. Reference Source
PATH: Strengthening human milk banking: a resources toolkit for establishing and integrating human milk bank programs—a training curriculum template for hospital and human milk bank staff. 2019b.
PATH: Strengthening Human Milk Banking. 2025. Reference Source
Quigley M, Embleton ND, Meader N, et al.: Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants. Cochrane Database Syst Rev. 2024; 9(9): CD002971. PubMed Abstract | Publisher Full Text | Free Full Text
Sisk PM, Lovelady CA, Dillard RG, et al.: Early human milk feeding is associated with a lower risk of necrotizing enterocolitis in very low birth weight infants. J Perinatol. 2007; 27(7): 428–433. PubMed Abstract | Publisher Full Text
Tricco AC, Lillie E, Zarin W, et al.: PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med. 2018; 169(7): 467–473. PubMed Abstract | Publisher Full Text
Tudehope DI: Human milk and the nutritional needs of preterm infants. J Pediatr. 2013; 162(3 Suppl): S17–S25. PubMed Abstract | Publisher Full Text
Victora CG, Bahl R, Barros AJD, et al.: Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016; 387(10017): 475–490. PubMed Abstract | Publisher Full Text
World Health Organization: WHO recommendations for care of the preterm or low‐birth‐weight Infant. 2022. PubMed Abstract
World Health Organization: Guidelines on optimal feeding of low birth weight infants in low‐ and middle‐income countries. 2011. PubMed Abstract

Comments on this article Comments (0)

Version 2

VERSION 2 PUBLISHED 19 Jun 2025

Author details Author details

Roisin O'Donovan
Roles: Conceptualization, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Aoife Long
Roles: Conceptualization, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Elaine Lehane
Roles: Conceptualization, Investigation, Methodology, Project Administration, Supervision, Writing – Review & Editing

Helen Mulcahy
Roles: Investigation, Methodology, Supervision, Writing – Review & Editing

Siobhan Ward
Roles: Writing – Review & Editing

Margaret Murphy
Roles: Writing – Review & Editing

Susan Rogers
Roles: Writing – Review & Editing

Gillian Weaver
Roles: Conceptualization, Supervision, Writing – Review & Editing

Patricia Leahy-Warren
Roles: Conceptualization, Methodology, Project Administration, Supervision, Writing – Review & Editing

Competing interests

Gillian Weaver has no commercial or corporate conflicts of interest in this area. However, she would like to declare her role as co-founder of a non profit human milk bank- Human Milk Foundation. All other authors have no conflict of interest to declare.

Grant information

Health Research Board -APRO-2023-015
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (2)

version 2

Revised

Published: 28 Aug 2025, 8:69

https://doi.org/10.12688/hrbopenres.14180.2

version 1

Published: 19 Jun 2025, 8:69

https://doi.org/10.12688/hrbopenres.14180.1

© 2025 O'Donovan R et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Download

Export To

metrics

VIEWS

135

downloads

Citations

SEE MORE DETAILS

CITE

how to cite this article

O'Donovan R, Long A, Lehane E et al. Human milk banking services: An umbrella review protocol [version 2; peer review: 1 approved]. HRB Open Res 2025, 8:69 (https://doi.org/10.12688/hrbopenres.14180.2)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

track

receive updates on this article

Track an article to receive email alerts on any updates to this article.

Open Peer Review

Version 2

VERSION 2

PUBLISHED 28 Aug 2025

Revised

Views

Reviewer Report 03 Sep 2025

Tengfei Li, University of North Carolina, Chapel Hill, USA

Approved

https://doi.org/10.21956/hrbopenres.15661.r49426

My comments were all addressed. ... Continue reading

CITE

Report a concern

Respond or Comment

Version 1

VERSION 1

PUBLISHED 19 Jun 2025

Views

Reviewer Report 14 Aug 2025

Tengfei Li, University of North Carolina, Chapel Hill, USA

Approved

https://doi.org/10.21956/hrbopenres.15595.r47944

The authors present a well-structured umbrella-review protocol that first supplies a clear, evidence-based rationale for studying human-milk-bank services, then lays out objectives, review questions and methods that follow JBI guidance. The planned search strategy—combining controlled vocabulary, proximity operators and grey-literature limits—and the accompanying data-extraction template together form a sound, transparent framework for identifying and synthesising relevant systematic reviews. I have some suggestions:
1) Several phrases (“milk sibling”, “milk shar”*) may retrieve much informal sharing literature unrelated to formal HMB services; consider keeping them only if scoping showed they appear in titles of relevant reviews.
2) specify screening depth (e.g. first 200 results sorted by relevance OR by year) to maintain reproducibility.
3) Expanding the extraction sheet with income tier and review-type fields will help organise results for the specific questions you posed. Your research questions explicitly compare middle- vs. high-income countries and will likely observe differences across review designs (systematic, scoping, qualitative meta-synthesis). Adding two columns "income tier" and "review type" to Table 4 makes it easy to sort data later.
Author Year Country Income tier Review type… other

There are some minor issues:
1) “World Health Organzation”, or should it be “Organization”?
2) "high-income counties" or "countries" ?
3) “HMB require operational sustainability”, or “HMB requires”.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Statistics; biostatistics; machine learning; imaging genetics analyses

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

CITE

Report a concern

Author Response 18 Sep 2025

Roisin O'Donovan, University College Cork School of Nursing and Midwifery, Cork, Ireland

18 Sep 2025

Author Response

Thank you for your review and feedback on our Umbrella Review protocol. In response to your suggestions:
1) We have kept our original search strategy as scoping searches found they ... Continue reading Thank you for your review and feedback on our Umbrella Review protocol. In response to your suggestions:
1) We have kept our original search strategy as scoping searches found they appeared in some relevant titles.
2) We have now specified that the depth of screening for Google Scholar was the first 100 results, sorted by relevance. All identified items were screening for the other databases.
3) We have added “review type” to Table 4. However, once we completed screening for this review, it was clear that it would not be possible to filter reviews by country. Identified reviews included studies conducted in both high and low-and-middle-income countries or did not clearly report the countries for individual studies. Considering the goal of an Umbrella Review is to summarize or synthesize the findings of systematic reviews, and not individual studies, we did not exclude studies or findings from lower-income countries. Therefore, our results are not restricted to middle- and high income countries, as originally planned in our study protocol.
Minor issues:
We have now corrected each of these typos in the updated version of our protocol.
Thank you for your review and feedback on our Umbrella Review protocol. In response to your suggestions:
1) We have kept our original search strategy as scoping searches found they appeared in some relevant titles.
2) We have now specified that the depth of screening for Google Scholar was the first 100 results, sorted by relevance. All identified items were screening for the other databases.
3) We have added “review type” to Table 4. However, once we completed screening for this review, it was clear that it would not be possible to filter reviews by country. Identified reviews included studies conducted in both high and low-and-middle-income countries or did not clearly report the countries for individual studies. Considering the goal of an Umbrella Review is to summarize or synthesize the findings of systematic reviews, and not individual studies, we did not exclude studies or findings from lower-income countries. Therefore, our results are not restricted to middle- and high income countries, as originally planned in our study protocol.
Minor issues:
We have now corrected each of these typos in the updated version of our protocol.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 18 Sep 2025

Roisin O'Donovan, University College Cork School of Nursing and Midwifery, Cork, Ireland

18 Sep 2025

Author Response

Thank you for your review and feedback on our Umbrella Review protocol. In response to your suggestions:
1) We have kept our original search strategy as scoping searches found they ... Continue reading Thank you for your review and feedback on our Umbrella Review protocol. In response to your suggestions:
1) We have kept our original search strategy as scoping searches found they appeared in some relevant titles.
2) We have now specified that the depth of screening for Google Scholar was the first 100 results, sorted by relevance. All identified items were screening for the other databases.
3) We have added “review type” to Table 4. However, once we completed screening for this review, it was clear that it would not be possible to filter reviews by country. Identified reviews included studies conducted in both high and low-and-middle-income countries or did not clearly report the countries for individual studies. Considering the goal of an Umbrella Review is to summarize or synthesize the findings of systematic reviews, and not individual studies, we did not exclude studies or findings from lower-income countries. Therefore, our results are not restricted to middle- and high income countries, as originally planned in our study protocol.
Minor issues:
We have now corrected each of these typos in the updated version of our protocol.
Thank you for your review and feedback on our Umbrella Review protocol. In response to your suggestions:
1) We have kept our original search strategy as scoping searches found they appeared in some relevant titles.
2) We have now specified that the depth of screening for Google Scholar was the first 100 results, sorted by relevance. All identified items were screening for the other databases.
3) We have added “review type” to Table 4. However, once we completed screening for this review, it was clear that it would not be possible to filter reviews by country. Identified reviews included studies conducted in both high and low-and-middle-income countries or did not clearly report the countries for individual studies. Considering the goal of an Umbrella Review is to summarize or synthesize the findings of systematic reviews, and not individual studies, we did not exclude studies or findings from lower-income countries. Therefore, our results are not restricted to middle- and high income countries, as originally planned in our study protocol.
Minor issues:
We have now corrected each of these typos in the updated version of our protocol.
Competing Interests: No competing interests were disclosed. Close
Report a concern

Comments on this article Comments (0)

Version 2

VERSION 2 PUBLISHED 19 Jun 2025

Open Peer Review

Reviewer Status

Reviewer Reports

	Invited Reviewers
	1
Version 2 (revision) 28 Aug 25	read
Version 1 19 Jun 25	read

Tengfei Li, University of North Carolina, Chapel Hill, USA

Comments on this article

All Comments(0)

Add a comment

Back to all reports

Reviewer Report

4 Views

03 Sep 2025 | for Version 2

Tengfei Li, University of North Carolina, Chapel Hill, USA

4 Views Cite this report Responses(0)

Approved

My comments were all addressed. I have no other concerns

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Statistics; biostatistics; machine learning; imaging genetics analyses

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

10 Views

14 Aug 2025 | for Version 1

Tengfei Li, University of North Carolina, Chapel Hill, USA

10 Views Cite this report Responses(1)

Approved

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Statistics; biostatistics; machine learning; imaging genetics analyses

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (1)

Author Response

18 Sep 2025

Roisin O'Donovan, University College Cork School of Nursing and Midwifery, Cork, Ireland

Thank you for your review and feedback on our Umbrella Review protocol. In response to your suggestions:
1) We have kept our original search strategy as scoping searches found they appeared in some relevant titles.
2) We have now specified that the depth of screening for Google Scholar was the first 100 results, sorted by relevance. All identified items were screening for the other databases.
3) We have added “review type” to Table 4. However, once we completed screening for this review, it was clear that it would not be possible to filter reviews by country. Identified reviews included studies conducted in both high and low-and-middle-income countries or did not clearly report the countries for individual studies. Considering the goal of an Umbrella Review is to summarize or synthesize the findings of systematic reviews, and not individual studies, we did not exclude studies or findings from lower-income countries. Therefore, our results are not restricted to middle- and high income countries, as originally planned in our study protocol.
Minor issues:
We have now corrected each of these typos in the updated version of our protocol.

View more View less

Competing Interests

No competing interests were disclosed.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

[1] Aromataris E, Fernandez R, Godfrey C, et al.: Umbrella reviews. In: JBI Manual for Evidence Synthesis. JBI, 2024. Publisher Full Text

[2] Aromataris E, Munn Z, eds.: JBI manual for evidence synthesis. JBI, 2020.

[3] Cleminson JS, Zalewski SP, Embleton ND: Nutrition in the preterm infant: what’s new? Curr Opin Clin Nutr Metab Care. 2016; 19(3): 220–225. PubMed Abstract

[4] Corpeleijn WE, Kouwenhoven SMP, Paap MC, et al.: Intake of own mother’s milk during the first days of life is associated with decreased morbidity and mortality in very low birth weight infants during the first 60 days of life. Neonatology. 2012; 102(4): 276–281. PubMed Abstract | Publisher Full Text

[5] Herson M, Weaver G: A comparative review of human milk banking and national tissue banking programs. Matern Child Nutr. 2024; 20 Suppl 4(Suppl 4): e13584. PubMed Abstract | Publisher Full Text | Free Full Text

[6] Human Milk Bank Global Map: Human milk bank global map tableau. 2019. Reference Source

[7] Israel‐Ballard K, LaRose E, Mansen K: The global status of human milk banking. Matern Child Nutr. 2024; 20 Suppl 4(Suppl 4): e13592. PubMed Abstract | Publisher Full Text | Free Full Text

[8] Klotz D, Wesołowska A, Bertino E, et al.: The legislative framework of donor human milk and human milk banking in Europe. Matern Child Nutr. 2022; 18(2): e13310. PubMed Abstract | Publisher Full Text | Free Full Text

[9] Lapidaire W, Lucas A, Clayden JD, et al.: Human milk feeding and cognitive outcome in preterm infants: the role of infection and NEC reduction. Pediatr Res. 2022; 91(5): 1207–1214. PubMed Abstract | Publisher Full Text | Free Full Text

[10] Lucas A, Cole TJ: Breast milk and neonatal necrotising enterocolitis. Lancet. 1990; 336(8730–8731): 1519–1523. PubMed Abstract | Publisher Full Text

[11] Meinzen-Derr J, Poindexter B, Wrage L, et al.: Role of human milk in extremely low birth weight infants’ risk of necrotizing enterocolitis or death. J Perinatol. 2009; 29(1): 57–62. PubMed Abstract | Publisher Full Text | Free Full Text

[12] Ong ML, Belfort MB: Preterm infant nutrition and growth with a human milk diet. Semin Perinatol. 2021; 45(2): 151383. PubMed Abstract | Publisher Full Text

[13] O'Donovan R: HMB_Umbrella_Protocol_PRISMA-P-SystRev-checklist. Zenodo. 2025. http://www.doi.org/10.5281/zenodo.15624176

[14] PATH: Strengthening human milk banking: a resource toolkit for establishing & integrating human milk bank programs—a global implementation framework. 2019a. Reference Source

[15] PATH: Strengthening human milk banking: a resources toolkit for establishing and integrating human milk bank programs—a training curriculum template for hospital and human milk bank staff. 2019b.

[16] PATH: Strengthening Human Milk Banking. 2025. Reference Source

[17] Quigley M, Embleton ND, Meader N, et al.: Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants. Cochrane Database Syst Rev. 2024; 9(9): CD002971. PubMed Abstract | Publisher Full Text | Free Full Text

[18] Sisk PM, Lovelady CA, Dillard RG, et al.: Early human milk feeding is associated with a lower risk of necrotizing enterocolitis in very low birth weight infants. J Perinatol. 2007; 27(7): 428–433. PubMed Abstract | Publisher Full Text

[19] Tricco AC, Lillie E, Zarin W, et al.: PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med. 2018; 169(7): 467–473. PubMed Abstract | Publisher Full Text

[20] Tudehope DI: Human milk and the nutritional needs of preterm infants. J Pediatr. 2013; 162(3 Suppl): S17–S25. PubMed Abstract | Publisher Full Text

[21] Victora CG, Bahl R, Barros AJD, et al.: Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016; 387(10017): 475–490. PubMed Abstract | Publisher Full Text

[22] World Health Organization: WHO recommendations for care of the preterm or low‐birth‐weight Infant. 2022. PubMed Abstract

[23] World Health Organization: Guidelines on optimal feeding of low birth weight infants in low‐ and middle‐income countries. 2011. PubMed Abstract

Human milk banking services: An umbrella review protocol

Abstract

Objective

Introduction

Inclusion criteria

Methods

Keywords

Revised Amendments from Version 1

Introduction

Objective

Research questions

Methods and analysis

Design

Inclusion criteria

Search strategy

Table 1. Developing the Search Strategy.

Table 2. Search Strategy.

Table 3. Full Sample Search String for CINAHL.

Screening

Data extraction

Table 4. Data Extraction Instrument.

Data analysis

Quality assessment

Data summary

Ethics and consent

Data availability statement

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Are you a HRB-funded researcher?

Thank you!

Human milk banking services: An umbrella review protocol

Abstract

Objective

Introduction

Inclusion criteria

Methods

Keywords

Revised Amendments from Version 1

Introduction

Objective

Research questions

Methods and analysis

Design

Inclusion criteria

Search strategy

Table 1. Developing the Search Strategy.

Table 2. Search Strategy.

Table 3. Full Sample Search String for CINAHL.

Screening

Data extraction

Table 4. Data Extraction Instrument.

Data analysis

Quality assessment

Data summary

Ethics and consent

Data availability statement

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Competing Interests Policy

Stay Updated

Are you a HRB-funded researcher?

Thank you!