Improving Health Outcomes for New Mothers and Babies
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00360204
Recruitment Status :
First Posted : August 4, 2006
Last Update Posted : July 28, 2017
Milton S. Hershey Medical Center
Department of Health and Human Services
Health Resources and Services Administration (HRSA)
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.
Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery [ Time Frame: 3 years ]
Secondary Outcome Measures :
Adherence to continuity of care guidelines [ Time Frame: 3 years ]
Postpartum anxiety [ Time Frame: 3 years ]
Breastfeeding duration [ Time Frame: 3 years ]
Maternal satisfaction with post-discharge healthcare [ Time Frame: 3.5 years ]
Parenting sense of competence [ Time Frame: 3.5 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
up to 7 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Ian M. Paul, MD, Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics, Milton S. Hershey Medical Center