Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
Information source: Mead Johnson Nutrition
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cow's Milk Allergy; Intolerance to Extensively Hydrolyzed Formulas; Intolerance to Breast Milk
Intervention: Amino Acid-based Formula with high DHA and ARA (Other); Amino Acid-based Formula with lower DHA and ARA (Other)
Phase: N/A
Status: Withdrawn
Sponsored by: Mead Johnson Nutrition Official(s) and/or principal investigator(s): Nikhil Thapar, M.D., Principal Investigator, Affiliation: UCL Institute of Child Health and Great Ormond Street Hospital
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.
Clinical Details
Official title: Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Primary outcome: Level of fatty acids in whole blood of infants
Secondary outcome: body weightOccurrence of allergic manifestations Occurrence of adverse events Incidence of gas Incidence of fussiness Stool characteristics Body length Head Circumference
Eligibility
Minimum age: N/A.
Maximum age: 6 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Great Ormand Street Hospital and Institute of Child Health, London, United Kingdon WC1N1EH, United Kingdom
Additional Information
Starting date: January 2012
Last updated: March 20, 2012
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