NCT01991613
Completed
Phase 2
Early Liquid Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
ConditionsGrowth in Premature Infants
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Growth in Premature Infants
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Growth velocity
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Andrea Weintraub
Associate Professor
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Growth velocity
Time Frame: up to 28 days
Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life
Secondary Outcomes
- weight(average 11 weeks)
- head circumference(average 11 weeks)
- Length(average 11 weeks)
Study Sites (1)
Loading locations...
Similar Trials
Active, not recruiting
Not Applicable
Early Protein Supplementation in Extremely Preterm Infants Fed Human MilkPrematurity; ExtremeFeeding Disorder NeonatalBreast Milk ExpressionGrowth FailureMicrobial ColonizationNCT04325308University of Alabama at Birmingham150
Unknown
Not Applicable
Nutrition of Premature Infants With Human Breastmilk FortifierGrowth AccelerationNCT03191617NEOCOSUR160
Not yet recruiting
Not Applicable
Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks GestationFeeding; Difficult, NewbornNCT06336668University of Calgary18
Completed
Phase 3
Evaluation of a Novel Human Milk Fortifier in Preterm InfantsPreterm InfantsNCT01373073Abbott Nutrition147
Unknown
Not Applicable
Human Milk in Preterm InfantsPreterm BirthNCT05228535Augusta University50