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

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

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.

Study Overview

• Status: Completed
• Conditions: Growth in Premature Infants
• Intervention / Treatment: Dietary supplement: liquid protein supplement

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: liquid protein supplement; The liquid protein supplement is already in use. The purpose of this study is to determine whether using the supplement earlier will lead to improved growth.; Other Names: Abbott liquid protein supplement
No Intervention: Control group; Study subjects will receive standard of care nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth velocity	Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	Extrauterine growth from birth until discharge from the NICU - Weekly weight measurements until discharge from the NICU	average 11 weeks
Length	Extrauterine growth from birth until discharge from the NICU - Weekly length measurements until discharge from the NICU	average 11 weeks
head circumference	Extrauterine growth from birth until discharge from the NICU - Weekly head circumference measurements until discharge from the NICU	average 11 weeks

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Andrea Weintraub, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: GCO 13-1422