Evaluation of Human Milk Fortifiers in Preterm Infants
- Conditions
- Infant Growth
- Interventions
- Other: Human Milk Fortifier BOther: Human Milk Fortifier A
- Registration Number
- NCT02307760
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- Birth weight of 700 g-1500 g.
- ≤ 32 weeks and 0 days GA at birth.
- Appropriate for GA (AGA).
- Enteral feeding of human milk 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 the plan is that it will be fortified.
- Parent(s) agrees to allow infant to receive both human milk and HMF.
- Singleton or twin births only.
- Enteral feeding of preterm infant formula or HMF for > 7 days.
- Expected to be transferred to another facility and will not be able to be followed for at least 15 days.
- Serious congenital abnormalities or underlying disease that may affect growth and development.
- 5 minute APGAR ≤ 4.
- Steroids used at the time of randomization.
- Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).
- Mechanical ventilator dependence.
- Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.
- 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 (24).
- Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Human Milk Fortifier B Human Milk Fortifier B Non-acidified processing method. Study Human Milk Fortifier A Human Milk Fortifier A Acidified processing method.
- Primary Outcome Measures
Name Time Method Weight Gain Study Day 1 to Study Day 29 (or discharge, whichever happens first) scale measurement g/kg/d
- Secondary Outcome Measures
Name Time Method Gastrointestinal Tolerance Study Day 1 to Study Day 29 (or discharge, whichever happens first) healthcare professional completed questionnaire
Length Study Day 1 to Study Day 29 (or discharge, whichever happens first) measured cm/wk
Head Circumference Study Day 1 to Study Day 29 (or discharge, whichever happens first) measured cm/wk
Trial Locations
- Locations (18)
University of South Alabama Children's and Women's Hospital
🇺🇸Mobile, Alabama, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
All Children's Hospital / Johns Hopkins
🇺🇸Saint Petersburg, Florida, United States
South Miami Hospital
🇺🇸Miami, Florida, United States
Cohen Children's Medical Center of NY at North Shore
🇺🇸Manhasset, New York, United States
Cohen Children's Medical Center of NY
🇺🇸New Hyde Park, New York, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Doctors Hospital at Renaissance/Women's Hospital at Renaissance
🇺🇸Edinburg, Texas, United States
Texas Health and Education Institute
🇺🇸Fort Worth, Texas, United States
North Central Baptist Hospital
🇺🇸San Antonio, Texas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Medstar Georgetown University Hospital
🇺🇸Washington, D.C., District of Columbia, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Wheaton Franciscan Heathcare Inc.- St. Joseph
🇺🇸Milwaukee, Wisconsin, United States
Banner - University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States