NCT02073071
Completed
Not Applicable
Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
ConditionsOther Preterm Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Other Preterm Infants
- Sponsor
- Abbott Nutrition
- Enrollment
- 139
- Locations
- 10
- Primary Endpoint
- Weight
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This is a two stage open-label, single-arm, multicenter and observational study.
Detailed Description
Stage 1: In hospital, preterm/low birth weight infants less than or equal to 34 weeks gestational age at birth, birth weight of ≥ 1000g to \<1800g and conditions meeting the enrollment criteria will be fed formula with or without parenteral nutrition until discharge. Stage 2: Post-discharge, all infants with birth weight \< or =1500g will be followed on formula per standard of care and accepted standard of care including feeding until the infant's weight \>or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Weight
Time Frame: Change from first feeding to discharge (up to ~8 weeks)
Secondary Outcomes
- Length(Change from first feeding to discharge (up to ~8 weeks))
- Head Circumference(Change from first feeding to discharge (up to ~8 weeks))
- Hospitalization Length of Stay(Time from Birth to discharge (up to ~8 weeks))
- Gastrointestinal Tolerance(From first feeding to discharge (up to ~8 weeks))
- Catch Up Growth(From discharge to 9 months corrected age)
Study Sites (10)
Loading locations...
Similar Trials
Completed
Not Applicable
To Investigate Effects of a New Infant Formula in Healthy Term Chinese InfantsHealthy InfantsNCT03520764Danone Nutricia284
Terminated
Phase 3
Growth and Tolerance of Healthy Term Infants to a New Infant FormulaHealthy Term InfantsNCT01137877Abbott Nutrition399
Terminated
Not Applicable
Growth and Tolerance Trial on Infant Formula With HMOHealthy GrowthNCT04066413FrieslandCampina265
Completed
Not Applicable
The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term InfantsHealthyNCT06256094a2 Milk Company Ltd.280
Completed
Not Applicable
BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)GrowthNCT04957992Abbott Nutrition607