Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital

Completed · Phase 2/Phase 3

Conditions studied: Pre-term Infants

In brief

The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments.

Key facts

Study ID

NCT01766011

Run by

Abbott Nutrition

People needed

28

Starts

2012-11-01

Expected to finish

2013-10-01

Last updated by the study team

2015-03-03

Who can join

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

You may qualify if…

• Subjects eligible for study participation will satisfy the following criteria:
• Birth weight between 1000g -1800g
• Less than or equal to 34 weeks and 0 days gestational age at birth
• Appropriate for gestational age (AGA)
• Singleton or twin births
• Infant is 21 days of age or less

You may not qualify if…

• Infants with the following conditions prior to and/or at the time of study product initiation are not eligible for entry into the study:
• Expected to be transferred to another facility within 14 days
• Serious congenital abnormalities that may affect growth and development
• Intubated for ventilation at the time of study product initiation
• Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH)
• Maternal incapacity, maternal drug or alcohol abuse during pregnancy or current abuse, or maternal treatment consistent with human immunodeficiency virus therapy
• Infant has a history of major surgery
• Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia
• Confirmed necrotizing enterocolitis or confirmed sepsis
• Current use or planned use of probiotics
• Participation in another study that has not been approved

Where it is running

• University of South Alabama - Children's and Women's Hospital — Mobile, Alabama, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Wesley Medical Center — Wichita, Kansas, United States
• Maria Children's Hospital Westchester Medical Center — Valhalla, New York, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Wheaton Franciscan Healthcare-St. Joseph — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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