Status:
WITHDRAWN
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
Lead Sponsor:
Mead Johnson Nutrition
Conditions:
Cow's Milk Allergy
Intolerance to Extensively Hydrolyzed Formulas
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.
Eligibility Criteria
Inclusion
- 0 to 6 months of age inclusive
- Born at ≥ 37 weeks gestation
- Birth weight of 2500 g (5 lb 8 oz) or more
- Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk
- Infants with symptoms suggestive of cow's milk allergy
- Signed Informed Consent
Exclusion
- Infants who for whatever reasons were not discharged home as per routine
- Infants with metabolic illness requiring a special formula
- Infants fed with nasogastric tube
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01470768
Start Date
January 1 2012
End Date
December 1 2013
Last Update
March 22 2012
Active Locations (1)
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1
Great Ormand Street Hospital and Institute of Child Health
London, United Kingdon, United Kingdom, WC1N1EH