Preterm Infants Fed a Human Milk Fortifier
- Conditions
- Growth
- Interventions
- Other: Control ProductOther: Experimental Product 1Other: Experimental Product 2
- Registration Number
- NCT05551975
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 321
- 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)
- Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if fortified with study fortifier and use of mother's own milk (when available) is prioritized.
- Parent(s) agrees to allow infant to receive both human milk and study HMF.
- Singleton or twin births only.
- Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.
- 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.
- Receiving systemic steroids at time of randomization.
- Receiving probiotics at time of randomization.
- Grade Ill or IV PVH/IVH.
- Dependent on invasive ventilation at time of randomization.
- Maternal incapacity.
- Mother or infant is currently receiving treatment consistent with HIV therapy.
- Documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse.
- Positive toxicology report for cocaine, opiates, or methamphetamine in mother or infant.
- Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
- Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score <3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas < 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life.
- Confirmed NEC (Bell's Stage II or III).
- Confirmed current sepsis.
- Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.
- Participation in another study that has not been approved as a concomitant study by AN.
- Participant has an allergy or intolerance to any ingredient in study fortifier.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Product Control Product Control Human Milk Fortifier added to human milk feedings Product 1 Experimental Product 1 Study Human Milk Fortifier added to human milk feedings Product 2 Experimental Product 2 Study Human Milk Fortifier added to human milk feedings
- Primary Outcome Measures
Name Time Method Weight Study Day 1 to Study Day 29 or Hospital Discharge if first Weight gain per day
- Secondary Outcome Measures
Name Time Method Weight Study Day 1 to Study Day 15 Weight gain per day
Head Circumference Study Day 1 to Study Day 15 and Study Day 29 Head circumference gains per week
Feeding Intolerance Study Day 1 to Study Day 29 Percent periods NPO, feedings withheld due to gastrointestinal intolerance
Length Study Day 1, 8, 15, 22, 29 and Hospital Discharge Attained length in cm
Head Circumference (HC) Study Day 1, 8, 15, 22, 29 and Hospital Discharge Attained HC in cm
Full Enteral Feeds Study Day 1 to Study Day 29 Days to achieve full enteral feeds
Stool Characteristics Study Day 1 to Study Day 29 Percent bloody, black, watery, or hard stools
Trial Locations
- Locations (14)
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
South Miami Hospital
🇺🇸Miami, Florida, United States
St. Luke's Baptist Hospital
🇺🇸San Antonio, Texas, United States
The Woman's Hospital of Texas
🇺🇸Houston, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of New Mexico Children's Hospital
🇺🇸Albuquerque, New Mexico, United States
WVU Medicine Children's Hospital
🇺🇸Morgantown, West Virginia, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
UAMS Medical Center
🇺🇸Little Rock, Arkansas, United States
Banner - University Medical Center
🇺🇸Phoenix, Arizona, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
AdventHealth
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States