Improving Health Outcomes for New Mothers and Babies

NCT00360204 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1154

Last updated 2017-07-28

No results posted yet for this 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.

Conditions

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00360204 on ClinicalTrials.gov