NCT02632266

Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 28 Weeks – 34 Weeks
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Complication of Prematurity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Powder HMF	powder human milk fortifier
DIETARY_SUPPLEMENT	Liquid HMF	Liquid human milk fortifier

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2015-12-16
• Last updated: 2020-09-03

Locations

1 site across 1 country: United States