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Improving Health Outcomes for New Mothers and Babies

This study has been completed.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
HRSA/Maternal and Child Health Bureau
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00360204
First received: August 3, 2006
Last updated: March 9, 2011
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Hyperbilirubinemia
Jaundice
Dehydration
Postpartum Depression
Behavioral: Home Nurse Visit
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving Health Outcomes for New Mothers and Babies

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to continuity of care guidelines [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Postpartum anxiety [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Breastfeeding duration [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Maternal satisfaction with post-discharge healthcare [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
  • Parenting sense of competence [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
  • Cost of care [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1154
Study Start Date: September 2006
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Home Nurse Visit
    Home nurse visit by maternal child health nurse within first 24-48 after post-partum hospital discharge.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 7 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Triplets or higher order gestation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360204

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Health Resources and Services Administration (HRSA)
HRSA/Maternal and Child Health Bureau
Investigators
Principal Investigator: Ian M Paul, MD, MSc Penn State Milton S. Hershey Children's Hospital
  More Information

Additional Information:
No publications provided by Penn State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ian M. Paul, MD, MSc, Penn State Children's Hospital, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00360204     History of Changes
Other Study ID Numbers: 22163, R40 MC 06630-01
Study First Received: August 3, 2006
Last Updated: March 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Infant health
parenting competence
Home nurse visit
maternal post-partum care
postpartum health utilization
Breastfeeding

Additional relevant MeSH terms:
Dehydration
Depression
Depression, Postpartum
Hyperbilirubinemia
Behavioral Symptoms
Depressive Disorder
Mental Disorders
Metabolic Diseases
Mood Disorders
Pathologic Processes
Pregnancy Complications
Puerperal Disorders
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on November 20, 2014