Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants
Status: | Recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | Any |
Updated: | 10/20/2018 |
Start Date: | July 2015 |
End Date: | July 2019 |
Contact: | Amie Slaughter |
Email: | AGRIMM@kumc.edu |
Phone: | (913) 588-6350 |
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.
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.
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.
Inclusion Criteria:
- Inborn preterm infants born between 28 0/7 and 34 0/7 weeks gestation and fed either
mother's own milk or donor human milk
Exclusion Criteria:
- Newborn infants <28 weeks and >34 weeks gestation, those with life threatening
illness, congenital and chromosomal anomalies, gastrointestinal anomalies or
necrotizing enterocolitis and fed premature formula
We found this trial at
1
site
3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Mitzi Go, MD
Phone: 913-588-6350
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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