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

Study Overview
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Brief Summary
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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.

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

Conditions
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Growth in Premature Infants

Intervention / Treatment
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* Dietary Supplement: liquid protein supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 33 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: liquid protein supplement<br>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. | Dietary Supplement: liquid protein supplement<br>* 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.<br>* Other names: Abbott liquid protein supplement;|
| No Intervention: Control group<br>Study subjects will receive standard of care nutrition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | Extrauterine growth from birth until discharge from the NICU - Weekly weight measurements until discharge from the NICU | average 11 weeks | 
| Length | Extrauterine growth from birth until discharge from the NICU - Weekly length measurements until discharge from the NICU | average 11 weeks | 
| head circumference | Extrauterine growth from birth until discharge from the NICU - Weekly head circumference measurements until discharge from the NICU | average 11 weeks |