Nutritional Study in Preterm Infants
Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants
1 other identifier
interventional
206
1 country
8
Brief Summary
An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2005
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 27, 2008
CompletedFirst Posted
Study publicly available on registry
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedApril 27, 2009
September 1, 2008
3.3 years
June 27, 2008
April 24, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants
variable
Secondary Outcomes (1)
Measures of eye function, ROP, measures of skin lipid soluble compound concentration
variable
Study Arms (2)
Infant Formula
EXPERIMENTALPreterm infant formulas containing lipid soluble compounds
Preterm formulas
ACTIVE COMPARATORStandard preterm infant formula and discharge formulas
Interventions
Preterm infant formulas to be consumed per health care provider orders
Preterm infant formula to be fed per healthcare provider instructions
Eligibility Criteria
You may qualify if:
- Birthweight 500-1800 g
- Less than 33 wks gestational age
- Enteral feeding initiated by 21 days of life
- Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate
- Singleton or twin births only
- Infant is 21 days of age or less at time of randomization
You may not qualify if:
- Serious congenital abnormalities that may affect growth and development
- Grade III or IV intraventricular hemorrhage (IVH)
- Maternal incapacity
- History of major surgery
- Extracorporeal membrane oxygenation (ECMO)
- Asphyxia
- Confirmed NEC or positive blood cultures at the time of randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (8)
University of Alabama
Birmingham, Alabama, 35233, United States
West Coast Neonatalogy, All Children's Hospital
St. Petersburg, Florida, 33701, United States
University of South Florida
Tampa, Florida, 33606, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Maria Fareri Children's Hospital at Winchester Medical Center
Vahalla, New York, 10595, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Study Officials
- STUDY CHAIR
Bridget Barrett-Reis, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 1, 2008
Study Start
May 1, 2005
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
April 27, 2009
Record last verified: 2008-09