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The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.
This is a prospective, randomize, double-blinded study in preterm infants born between 28-34 weeks gestation admitted to the NICU at the University of Kansas Hospital. After obtaining informed consent, babies will be randomized to either liquid or powdered HMF using opaque, sealed envelopes with preassigned randomization. The feeding protocol as established in the KU NICU will be followed, beginning with initiation of trophic feeds, and advancement of enteral feeds depending on the gestational age and preceding illnesses. Once infants reach 80ml/kg/day of enteral feeds, human milk will be fortified to 22 kilocalories by adding either liquid or powdered fortifier. The beginning of the study(Study day 1) will be defined as reaching and tolerating 100ml/kg/day of 24 kilocalorie human milk fortified with either liquid or powdered fortifier. Enteral feeds will be advanced per unit protocol until they reach 150-160ml/kg/day and 110-120 kcal/kg/day. the volume of feeds will be adjusted based on the documented weight to provide energy and protein requirements as recommended by the ESPGHAN guidelines. Babies will be followed up until the time of NICU discharge.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
University of Kansas Medical Center
Kansas City, Kansas, United States
Start Date
July 1, 2015
Primary Completion Date
May 1, 2019
Completion Date
May 1, 2019
Last Updated
September 3, 2020
40
ACTUAL participants
Powder HMF
DIETARY_SUPPLEMENT
Liquid HMF
DIETARY_SUPPLEMENT
Lead Sponsor
University of Kansas Medical Center
Data Source & Attribution
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