Cow's Milk Allergy, Intolerance to Breast Milk, Intolerance to Extensively Hydrolyzed Formulas
Conditions
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.
Interventions
OTHERAmino Acid-based Formula with high DHA and ARA
OTHERAmino Acid-based Formula with lower DHA and ARA
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of fatty acids in whole blood of infants | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of allergic manifestations | 4 months |
| Occurrence of adverse events | 4 months |
| Incidence of gas | 4 months |
| body weight | 4 months |
| Stool characteristics | 4 months |
| Body length | 4 months |
| Head Circumference | 4 months |
| Incidence of fussiness | 4 months |
Countries
United Kingdom
Outcome results
None listed