NCT01156493.

Trial name or title	Hydrolized protein formula for premature infants
Methods	Randomised controlled trial.
Participants	n = 118 Inclusion criteria Birth weight 500 g to 1500 g and < 32 weeks' GA who survived more than 3 days. Not yet started enteral full feeds. Study explained and parent/caregiver demonstrating understanding of given information. Informed consent signed. Exclusion criteria Chromosomal anomalies. Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia). Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) GI pathology precluding oral feed and/or requiring major surgical or medical intervention. Parental refusal. Prior enrolment into a conflicting clinical trial. Conflicting clinical trials will be those in which the intervention could modify the outcome of the present study, for example, studies conducted to accelerate feeds and or improve tolerance.
Interventions	Protein hydrolysed formula. Standard premature formula.
Outcomes	Primary outcome measure: time to achieve full feeds. Secondary outcome measures: postnatal days to achieve full feeds.
Starting date	July 2010; study completion date: September 2015.
Contact information
Notes	ClinicalTrials.gov Identifier: NCT01156493. No report to date found.