Evaluation of Human Milk Fortifiers in Preterm Infants
Status
Completed
Conditions
Infant Growth
Treatments
Other: Human Milk Fortifier A
Other: Human Milk Fortifier B
Details and patient eligibility
About
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.
Enrollment
164 patients
Sex
All
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
164 participants in 2 patient groups
Study Human Milk Fortifier A
Active Comparator group
Description:
Acidified processing method.
Treatment:
Other: Human Milk Fortifier A
Study Human Milk Fortifier B
Experimental group
Description:
Non-acidified processing method.
Treatment:
Other: Human Milk Fortifier B
Trial contacts and locations
18
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Data sourced from clinicaltrials.gov
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