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Improving Health Outcomes for New Mothers and Babies

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ClinicalTrials.gov Identifier: NCT00360204
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Hyperbilirubinemia Jaundice Dehydration Postpartum Depression Behavioral: Home Nurse Visit Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Health Outcomes for New Mothers and Babies
Study Start Date : September 2006
Primary Completion Date : August 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Behavioral: Home Nurse Visit
    Home nurse visit by maternal child health nurse within first 24-48 after post-partum hospital discharge.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Adherence to continuity of care guidelines [ Time Frame: 3 years ]
  2. Postpartum anxiety [ Time Frame: 3 years ]
  3. Breastfeeding duration [ Time Frame: 3 years ]
  4. Maternal satisfaction with post-discharge healthcare [ Time Frame: 3.5 years ]
  5. Parenting sense of competence [ Time Frame: 3.5 years ]
  6. Cost of care [ Time Frame: 4 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360204

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
Milton S. Hershey Medical Center
Department of Health and Human Services
Health Resources and Services Administration (HRSA)
HRSA/Maternal and Child Health Bureau
Principal Investigator: Ian M Paul, MD, MSc Penn State Milton S. Hershey Children's Hospital
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ian M. Paul, MD, Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00360204     History of Changes
Other Study ID Numbers: 22163
R40 MC 06630-01
First Posted: August 4, 2006    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by Ian M. Paul, MD, Milton S. Hershey Medical Center:
Infant health
parenting competence
Home nurse visit
maternal post-partum care
postpartum health utilization

Additional relevant MeSH terms:
Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms