COLLABORATE trial to reduce mortality, NEC and cognitive impairment in babies born below 29 weeks’ gestation

We discuss COLLABORATE, a major UK-wide two-randomisation, adaptive, controlled trial to improve the care of preterm babies born below 29 weeks’ gestation. COLLABORATE aims to resolve two very longstanding uncertainties: whether preterm formula or pasteurised human donor milk is the better option to make up any shortfall in the availability of own mother’s milk, and whether human milk (own mother’s milk and pasteurised human donor milk) requires routine fortification with protein and carbohydrate. We explain the study rationale, design and importance for patients, their families and the NHS.

Corresponding author: Dr Neena Modi
Professor of Neonatal Medicine, School of Public Health, Imperial College London n.modi@imperial.ac.uk

For co-authors see Table 1

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Keywords

enteral nutrition; necrotising enterocolitis (NEC); cognitive development; human donor milk; preterm formula; fortifier

Key points

Non-definitive evidence suggests that preterm formula may increase the risk of necrotising enterocolitis, and pasteurised donor milk top-ups may increase the risk of neurodevelopmental impairment.
Routine fortification can achieve faster short-term growth, but needs more evidence to show long-term benefits.
Faster growth in growth restricted extremely preterm babies is a risk factor for later cardiometabolic disease.
Routine fortification risks providing too high an intake of protein, which is associated with adverse neuro-development and metabolic health.

Also published in Infant:

VOLUME 19 ISSUE 1/JANUARY 2023

Bovine-based breast milk fortifier and neonatal outcomes in premature infants of <32 weeks gestational age

Breast milk (maternal or donor) is the gold standard nutrition for preterm infants. Breast milk fortifier (BMF) provides supplementary nutrition to avoid the high growth failure rates in preterm infants. Conflicting reports have implicated BMF, especially bovine-based products, in the development of necrotising enterocolitis (NEC) and persistent safety concerns regarding BMF have led to variability in use across the UK and internationally. This study examines whether the use of bovine-based BMF in preterm infants plays a role in the development of NEC, or an increase in all-cause mortality.