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

NCT01991613 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2015-09-23

No results posted yet for this study

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.

Conditions

  • Growth in Premature Infants

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Andrea Weintraub, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
26 Weeks
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991613 on ClinicalTrials.gov