Status:
COMPLETED
Evaluation of Human Milk Fortifiers in Preterm Infants
Lead Sponsor:
Abbott Nutrition
Conditions:
Infant Growth
Eligibility:
All Genders
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT02307760
Start Date
December 1 2014
End Date
February 1 2017
Last Update
May 11 2017
Active Locations (18)
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1
University of South Alabama Children's and Women's Hospital
Mobile, Alabama, United States, 36604
2
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States, 85014
3
Yale University
New Haven, Connecticut, United States, 06520-8064
4
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007