A protocol for a randomised controlled trial exploring human milk, nutrition, growth, and breastfeeding rates at discharge: the Hummingbird study

Abstract

Abstract Background 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 (PF) or pasteurised donor human milk (DHM) may be used, although practice varies widely. Limited data suggest that the use of DHM may impact on maternal beliefs and behaviours and may therefore impact on breastfeeding rates. The aim of this pilot study is to determine if the duration of DHM exposure impacts on breastfeeding rates, and maternal breastfeeding self-efficacy. Methods The Human Milk, Nutrition, Growth, and Breastfeeding Rates at Discharge (Hummingbird) study is a feasibility and pilot, non-blinded, randomised controlled trial (RCT) with a contemporaneous qualitative evaluation. Babies born at less than 33 weeks gestation or with birth weight <1500 grams whose mothers intend to provide MOM are randomly assigned to either control arm (DHM used to make up shortfall until full feeds, then PF used thereafter) or intervention arm (DHM used to make up shortfall until 36 weeks corrected age or discharge if sooner). The primary outcome is breastfeeding rates at discharge. Secondary outcomes include growth, key 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 will be analysed using thematic analysis. Discussion The provision of DHM is a complex intervention as it impacts on infant health and disease, as well as impacting on maternal and healthcare staff belief and behaviour. This is the first RCT to investigate the impact of DHM duration on breastfeeding rates and maternal self-efficacy. Trial registration: Trial was registered prospectively on 4th May 2021 (ISRCTN 57339063).