Improving Health Outcomes for New Mothers and Babies

Completed · Phase 3

Conditions studied: Hyperbilirubinemia, Jaundice, Dehydration, Postpartum Depression

In brief

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 evaluate an alternative model of care and improve healthcare delivery to and reduce health disparities for "well" newborns and mothers after hospital discharge by using single postnatal home nurse visits. The principal investigator has previously shown a reduction in poor outcomes for infants who receive a home visit after discharge when studied retrospectively. The proposed research will build on the previous study and prospectively evaluate the impact of a single home nursing visit on morbidities and health disparities for newborns and mothers in a randomized, controlled trial involving 1154 mother/infant breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk period of infancy and motherhood, where medical and social problems can be recognized, anticipated, and/or treated, and can bridge the gap between hospital care and primary care. The investigators' program, The Nurses for Infants Through Teaching and Assessment after the NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation compared with guidelines-adherent outpatient clinic care.

Key facts

Study ID

NCT00360204

Run by

Milton S. Hershey Medical Center

People needed

1154

Starts

2006-09-01

Expected to finish

2010-02-01

Last updated by the study team

2017-07-28

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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