Exploring Human Milk, Nutrition, Growth, and Breastfeeding Rates at Discharge(HUMMINGBIRD Study): a protocol for a pilot randomised controlled trial
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
INTRODUCTION: Mother's own breast milk (MOM) is the optimal nutrition for preterm infants as it reduces the incidence of key neonatal morbidities and improves long-term outcomes. However, MOM shortfall is common and either preterm formula or pasteurised donor human milk (DHM) may be used, although practice varies widely. Limited data suggest that the use of DHM may impact maternal beliefs and behaviours and therefore breastfeeding rates. The aim of this pilot study is to determine if longer duration of DHM exposure increases breastfeeding rates, and if a randomised controlled trial (RCT) design is feasible. METHODS AND ANALYSIS: The Human Milk, Nutrition, Growth, and Breastfeeding Rates at Discharge (HUMMINGBIRD) Study is a feasibility and pilot, non-blinded RCT with a contemporaneous qualitative evaluation. Babies born less than 33 weeks' gestation or with birth weight <1500 g whose mothers intend to provide MOM are randomly assigned to either control (DHM used to make up shortfall until full feeds and preterm formula thereafter) or intervention (DHM used for shortfall until 36 weeks' corrected age or discharge if sooner). The primary outcome is breast feeding at discharge. Secondary outcomes include growth, neonatal morbidities, length of stay, breastfeeding self-efficacy and postnatal depression using validated questionnaires. Qualitative interviews using a topic guide will explore perceptions around use of DHM and analysed using thematic analysis. ETHICS APPROVAL AND DISSEMINATION: Nottingham 2 Research Ethics Committee granted approval (IRAS Project ID 281071) and recruitment commenced on 7 June 2021. Results will be disseminated in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN57339063.
Date Issued
2023-03-07
Date Acceptance
2023-02-10
Citation
BMJ Paediatrics Open, 2023, 7 (1)
ISSN
2399-9772
Publisher
BMJ Publishing Group
Journal / Book Title
BMJ Paediatrics Open
Volume
7
Issue
1
Copyright Statement
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/36882232
PII: 10.1136/bmjpo-2022-001803
Subjects
Animals
Birds
Breast Feeding
Female
Humans
Infant
Infant, Newborn
Infant, Very Low Birth Weight
Milk, Human
Mothers
Patient Discharge
Pilot Projects
Randomized Controlled Trials as Topic
Growth
Neonatology
Qualitative research
Publication Status
Published
Coverage Spatial
England
Article Number
ARTN e001803
Date Publish Online
2023-03-07