Evaluation of Human Milk Fortifiers in Preterm Infants

Completed · Not applicable

Conditions studied: Infant Growth

In brief

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.

Key facts

Study ID

NCT02307760

Run by

Abbott Nutrition

People needed

164

Starts

2014-12-01

Expected to finish

2017-02-01

Last updated by the study team

2017-05-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of South Alabama Children's and Women's Hospital — Mobile, Alabama, United States
• Banner - University Medical Center Phoenix — Phoenix, Arizona, United States
• Yale University — New Haven, Connecticut, United States
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• South Miami Hospital — Miami, Florida, United States
• All Children's Hospital / Johns Hopkins — St. Petersburg, Florida, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• University of Louisville — Louisville, Kentucky, 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
• Duke University Medical Center — Durham, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Doctors Hospital at Renaissance/Women's Hospital at Renaissance — Edinburg, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Texas Health and Education Institute — Fort Worth, Texas, United States
• North Central Baptist Hospital — San Antonio, Texas, United States
• Wheaton Franciscan Heathcare Inc.- St. Joseph — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.