Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT01470768
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT01470768
Study Brief:
Protocol Section:
NCT01470768