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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: Completed Phase 3 study, sponsored by Milton S. Hershey Medical Center.

NCT00360204 is a Phase 3 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 1,154 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 1,154 participants
Start Date 2006-09
Est. Completion 2010-02
Phase Phase 3
Milton S. Hershey Medical Center

396 total trials

What the finished NCT00360204 record still lists

NCT00360204 is an interventional study that assigns participants to a tested intervention. Its 1,154 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher).

The record links to 0 conditions, and to 1 intervention - of which Home Nurse Visit is the first listed.

NCT00360204 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00360204's enrollment target sits among peer trials

1,154 238th of 2000 higher than 1,763 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00360204, the US trial registry maintained by the National Library of Medicine. NCT00360204 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.