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

Phase 2CompletedNCT01991613

Icahn School of Medicine at Mount Sinai43 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Growth in Premature Infants

Interventions

liquid protein supplementDIETARY_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.

Eligibility

Sex: ALLMin age: 26 WeeksMax age: 33 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

Growth velocity

Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life

Time frame: up to 28 days

Secondary Outcomes

weight

Extrauterine growth from birth until discharge from the NICU - Weekly weight measurements until discharge from the NICU

Time frame: average 11 weeks

Length

Extrauterine growth from birth until discharge from the NICU - Weekly length measurements until discharge from the NICU

Time frame: average 11 weeks

head circumference

Extrauterine growth from birth until discharge from the NICU - Weekly head circumference measurements until discharge from the NICU

Time frame: average 11 weeks

Data from ClinicalTrials.gov

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