Improving Health Outcomes for New Mothers and Babies
NCT00360204 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1154
Last updated 2017-07-28
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 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.
Conditions
- Hyperbilirubinemia
- Jaundice
- Dehydration
- Postpartum Depression
Interventions
- BEHAVIORAL
-
Home Nurse Visit
Home nurse visit by maternal child health nurse within first 24-48 after post-partum hospital discharge.
Sponsors & Collaborators
-
Department of Health and Human Services
collaborator FED -
Health Resources and Services Administration (HRSA)
collaborator FED -
HRSA/Maternal and Child Health Bureau
collaborator FED -
Milton S. Hershey Medical Center
lead OTHER
Principal Investigators
-
Ian M Paul, MD, MSc · Penn State Milton S. Hershey Children's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Day
- Max Age
- 7 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-09-30
- Primary Completion
- 2009-08-31
- Completion
- 2010-02-28
Countries
- United States
Study Locations
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