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

Completed · Phase 2

Conditions studied: Growth in Premature Infants

In brief

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.

Key facts

Study ID

NCT01991613

Run by

Icahn School of Medicine at Mount Sinai

People needed

43

Starts

2013-12-01

Expected to finish

2015-06-01

Last updated by the study team

2015-09-23

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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