Cow's Milk Allergy Clinical Trial
Official title:
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 6 Months |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United Kingdom | Great Ormand Street Hospital and Institute of Child Health | London | United Kingdon |
Lead Sponsor | Collaborator |
---|---|
Mead Johnson Nutrition |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of fatty acids in whole blood of infants | 4 months | No | |
Secondary | body weight | 4 months | No | |
Secondary | Occurrence of allergic manifestations | 4 months | No | |
Secondary | Occurrence of adverse events | 4 months | No | |
Secondary | Incidence of gas | 4 months | No | |
Secondary | Incidence of fussiness | 4 months | No | |
Secondary | Stool characteristics | 4 months | No | |
Secondary | Body length | 4 months | No | |
Secondary | Head Circumference | 4 months | No |
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