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

Mount Sinai Health System

Status and phase: Completed; Phase 2

Conditions: Growth in Premature Infants

Treatments: Dietary Supplement: liquid protein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01991613

GCO 13-1422

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 26 to 33 weeks old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

liquid protein supplement

Experimental group

Description:

Study subjects will receive standard of care nutrition with the addition of a liquid protein supplement when the baby is able to tolerate an enteral feeding volume of 40mL/kg/day.

Treatment:

Dietary Supplement: liquid protein supplement

Control group

No Intervention group

Description:

Study subjects will receive standard of care nutrition