Status:
COMPLETED
Improving Health Outcomes for New Mothers and Babies
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Department of Health and Human Services
Health Resources and Services Administration (HRSA)
Conditions:
Hyperbilirubinemia
Jaundice
Eligibility:
All Genders
1-7 years
Phase:
PHASE3
Brief Summary
Because adherence to postnatal care guidelines across the United States (U.S.) is poor, newborns and mothers often are placed at undue risk for adverse medical and social outcomes. This study aims to ...
Detailed Description
In the NITTANY Initiative the effectiveness of a single postnatal/postpartum home nurse visit will be evaluated prospectively and compared with outpatient clinic-based care using a randomized, control...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
1154 Patients enrolled
Trial Details
Trial ID
NCT00360204
Start Date
September 1 2006
End Date
February 1 2010
Last Update
July 28 2017
Active Locations (2)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
2
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033