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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00360204
Eligibility Criteria:
Inclusion Criteria:
* Full term or late pre-term infant (\> 34 0/7 weeks gestational age) discharged from the newborn nursery
* Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
* English speaking mother
* Singleton or twin infant
Exclusion Criteria:
* Premature infant \< 34 weeks gestational age
* Exclusively formula fed infant during nursery stay
* Complicated maternity/nursery stay requiring \> 2 night stay after a vaginal delivery or \> 4 night stay after a cesarean section
* A nursery course with atypical complications (e.g. a work-up for ambiguous genitalia)
* Infant with hyperbilirubinemia requiring phototherapy during the nursery stay
* Any major maternal morbidities and/or pre-existing condition that would effect postpartum care such as cancer, multiple sclerosis, lupus, etc.
* Previous maternal participation in the NITTANY trial
* Residence outside of the coverage area for the Visiting Nurses Association (VNA) of Central Pennsylvania
* Family with no active telephone number (home or cellular)
* Infant being put up for adoption
* Non-English speaking mother
* Family requiring a home visit due to Social Work or other staff request/order
* Triplets or higher order gestation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
7 Months
Study:
NCT00360204
Study Brief:
Protocol Section:
NCT00360204