Active — Not RecruitingNot Applicable

Targeted Fortification of Pasteurized Donor Human Milk

Singapore61 participantsStarted 2021-03-01

Plain-language summary

This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs). Pools of PDHM will be analyzed for macronutrient content using the Miris Human Milk Analyzer. The control arm will receive standard of care, which is PDHM without additional protein fortification. The intervention arm will receive PDHM with a fat content of 3.8g/dL or more, with additional protein fortification of 0.67g/dL. Primary outcome will be rate of malnutrition at hospital discharge or 37 weeks, whichever earlier. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.

Who can participate

Age range37 Weeks

SexALL

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Inclusion Criteria: * Birth weight less than or equal to 1500g * Born at our study hospital or transferred to study hospital within first week of life * Achieving at least 40ml/kg/day of enteral feeds by day 7 of life * Receiving at least 25% of pasteurized donor human milk within first 7 days of life Exclusion Criteria: * Diagnosed or suspected inborn errors of metabolism * Acute or chronic renal impairment * Congenital disease associated with significant growth impairment (including, but not limited to, Trisomy 21, neonatal encephalopathy and seizures, neonatal tumours, achondroplasia, complex congenital heart disease, anorectal malformations, gastrointestinal disorders)

What they're measuring

Malnutrition rate

Timeframe: Hospital discharge or 37 weeks gestation, whichever earlier

Trial details

NCT IDNCT04640805

SponsorKK Women's and Children's Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-09-21