| Methods |
RCT (double blind)
Randomisation sequence generated by computer, allocation by sealed envelopes |
| Participants |
Very low birth weight or very preterm infants (stratified by 2 birth weight categories (500 to 1000 g and 1001 to 1500 g)) who survived > 3 days after birth and for whom breast milk was not available or was insufficient for requirements |
| Interventions |
Empirical use of 100% whey protein partially hydrolysed preterm formula (n = 62) vs intact preterm formula (n = 73)
Breast milk allowed if available; different formulas given to supplement when no breast milk available (postrandomisation exclusion if breast milk > 25% of total enteral intake) |
| Outcomes |
Time to achieve full feeds
Number of days from initiating oral feeds to achieving full feeds
Mortality
Necrotising enterocolitis |
| Notes |
Principal investigator: Teresa del Moral, Department of Pediatrics, Miller School of Medicine, University of Miami, FL, USA
Contacted tdelmoral@miami.edu in July 2017 seeking data
Trial dates: 2004 to 2005
Funded by Nestle
Study discontinued because the increasingly common use of breast milk meant recruitment was much slower than planned (remains unreported June 2019) |
