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

Growth in Premature Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991613
• Other study ID #: GCO 13-1422
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2013
• Last updated: September 21, 2015
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 26 Weeks to 33 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Growth in Premature Infants

Intervention

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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	weight	Extrauterine growth from birth until discharge from the NICU - Weekly weight measurements until discharge from the NICU	average 11 weeks	No
Secondary	Length	Extrauterine growth from birth until discharge from the NICU - Weekly length measurements until discharge from the NICU	average 11 weeks	No
Secondary	head circumference	Extrauterine growth from birth until discharge from the NICU - Weekly head circumference measurements until discharge from the NICU	average 11 weeks	No