Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants

Phase 2

Completed

• Conditions: Growth in Premature Infants
• Interventions: Dietary Supplement: liquid protein supplement

• Registration Number: NCT01991613
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-25
• Study Start: 2013-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• inborn at Mount Sinai Medical Center
• gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
• plan by family for their infant to receive human milk feeds

Exclusion Criteria

• outborn infants
• gestational age < 26 0/7 weeks or > 33 0/7 weeks
• major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
• sepsis and/or other serious clinical complication precluding initiation of enteral feeds
• plan by family for their infant to receive primarily preterm infant formula.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liquid protein supplement	liquid protein supplement	Study subjects will receive standard of care nutrition with the addition of a liquid protein supplement when the baby is able to tolerate an enteral feeding volume of 40mL/kg/day.

Primary Outcome Measures

Name	Time	Method
Growth velocity	up to 28 days	Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life

Secondary Outcome Measures

Name	Time	Method
weight	average 11 weeks	Extrauterine growth from birth until discharge from the NICU - Weekly weight measurements until discharge from the NICU
head circumference	average 11 weeks	Extrauterine growth from birth until discharge from the NICU - Weekly head circumference measurements until discharge from the NICU
Length	average 11 weeks	Extrauterine growth from birth until discharge from the NICU - Weekly length measurements until discharge from the NICU

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States