Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Completed · Phase 3

Conditions studied: Preterm Infants

In brief

The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.

Key facts

Study ID

NCT01373073

Run by

Abbott Nutrition

People needed

147

Starts

2011-08-01

Expected to finish

2012-12-01

Last updated by the study team

2013-02-20

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 700-1500g birth weight
• 33 weeks or less gestational age
• Appropriate for gestational age
• Initiate enteral feeds of human milk by 21 days of life
• Mother provided exclusive human milk feeds
• Parents allow both human milk and study human milk fortifier
• Singleton or twin birth

You may not qualify if…

• Feeding preterm infant formula or non-study human milk fortifier
• Expected at facility less than 15 days
• Congenital anomalies/disease affecting growth and development
• 5 minute APGAR of 4 or less
• Steroid use
• ECMO
• Grade III or IV PVH/IVH
• Mechanical ventilator dependency
• Maternal incapacity
• History of major surgery
• Asphyxia
• Confirmed NEC or sepsis
• Use of probiotics

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• UCSD Medical Center — San Diego, California, United States
• University South Florida — Tampa, Florida, United States
• Memorial Hospital of Southbend — Southbend, Indiana, United States
• Wesley Medical Center — Wichita, Kansas, United States
• King's County Hospital Center — Brooklyn, New York, United States
• Cohen Children's Medical Center of New York at North Shore — Manhasset, New York, United States
• Cohen Children's Medical Center of NY at North Shore — New Hyde Park, New York, United States
• Childrens Hospital Westchester Medical Center — Valhalla, New York, United States
• University Hospitals Case Medical Center Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Toledo Children's Hospital — Toledo, Ohio, United States
• OHSU — Portland, Oregon, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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