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NCT00360204 · ClinicalTrials.gov registry record · Phase 3
Improving Health Outcomes for New Mothers and Babies
A Phase 3 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,154
- Enrollment target
NCT00360204 is a Phase 3 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 1,154 participants.
The verdict
NCT00360204, a Phase 3 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,154 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Home Nurse Visit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,154 participants |
| Start Date | 2006-09 |
| Est. Completion | 2010-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00360204
The ClinicalTrials.gov registry entry for NCT00360204 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Home Nurse Visit is the first listed.
NCT00360204 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00360204 about?
NCT00360204 is a clinical study titled "Improving Health Outcomes for New Mothers and Babies". 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 dispariti...
What is the current status of trial NCT00360204?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,154 participants. The study started on 2006-09. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00360204?
The interventions under investigation include: Home Nurse Visit (BEHAVIORAL).
Who is sponsoring clinical trial NCT00360204?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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