Preterm Infants Fed a Human Milk Fortifier
ConditionGrowth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAbbott Nutrition
About this trial
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
Eligibility criteria
Qualifiers
Birth weight between 700 g-1500 g.
≤ 32 weeks and 0 days GA at birth.
Participant has been classified as appropriate for GA (AGA).
Enteral feeding of human milk must be initiated by 21 days of life (birth date is day of life 0)
Disqualifiers
Enteral feeding of preterm infant formula or HMF for > 7 days.
Expected to be transferred to another facility within 30 days of randomization.
Serious congenital abnormalities or underlying disease that may affect growth and development.
5-minute APGAR ≤ 4.
Trial design
Treatments tested in this trial
- Control Product
- Experimental Product 1
- Experimental Product 2
Treatment groups
321 Participants
are divided into 3 treatment groupsLocations
14Arizona
Banner - University Medical Center85006, Phoenix United States
Arkansas
UAMS Medical Center72205, Little Rock United States
Connecticut
Connecticut Children's Medical Center06106, Hartford United States
Florida
South Miami Hospital33143, Miami United States
Sponsors and collaborators
Abbott Nutrition
Lead sponsor
Source ClinicalTrials.gov