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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01991613

Enrollment

Registered

2013-11-25

Start date

2013-12-31

Completion date

2015-06-30

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth in Premature Infants

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.

Interventions

DIETARY_SUPPLEMENTliquid 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

26 Weeks to 33 Weeks

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026