NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Active Not RecruitingNA
Sponsor: University of Alabama at Birmingham
Conditions: Prematurity, Light-For-Dates, Enteral Feeding Intolerance
Interventions: Early HMF, Delayed HMF
Countries: United States
In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.
Eligibility overview
Sex: ALL
Age: 1 Day to 4 Days
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Gestational age 29 to 33 weeks of gestation * Birth weight \< 1800 g * Postnatal age \< 96 hours Exclusion Criteria: * Small for gestational age (\<5th percentile) * Major congenital/chromosomal anomalies * Terminal illness needing withhold or limit support
Locations (1)
- Birmingham, Alabama, United States