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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT02221167
Eligibility Criteria:
Inclusion Criteria:
* Gestational age greater than or equal to 37 weeks
* Weight loss greater than or equal to 5% (rounded to nearest whole percent) of birth weight in the first 36 hours after birth
* Chronologic age of 24-48 hours old at the time of study enrollment
Exclusion Criteria:
* twins and higher level multiples
* infant has congenital or chromosomal anomalies that may affect feeding, diagnosed prior to study enrollment
* mother incarcerated
* mother's age \<18 years
* mother reports mature milk production prior to study enrollment
* mother does not speak English
* infants offered \> 1 supplemental feeding of formula or donor milk
* weight loss greater than 10%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Hours
Maximum Age:
48 Hours
Study:
NCT02221167
Study Brief:
Protocol Section:
NCT02221167