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Targeted Fortification of Pasteurized Donor Human Milk
Sponsor: KK Women's and Children's Hospital
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.
Official title: Targeted Fortification of Pasteurized Donor Human Milk to Improve Growth in Very Low Birth Weight Infants
Key Details
Gender
All
Age Range
Any - 37 Weeks
Study Type
INTERVENTIONAL
Enrollment
61
Start Date
2021-03-01
Completion Date
2025-12-01
Last Updated
2024-10-10
Healthy Volunteers
No
Interventions
Protein supplementation
Liquid protein fortifier (Similac) will be added at 1ml per 25ml of PDHM at 130ml/kg/day of feed volume.
Analysis with Miris Human Milk Analyzer
PDHM macronutrient content will be analyzed using the Miris Human Milk Analyzer and PDHM with fat content of 3.8g/dL or higher will be selected and provided.
Locations (1)
KK Women's and Children's Hospital
Singapore, Singapore