NCT00360204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,154

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2006

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2006

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

2.9 years

First QC Date

August 3, 2006

Last Update Submit

July 25, 2017

Conditions

HyperbilirubinemiaJaundiceDehydrationPostpartum Depression

Keywords

Infant healthparenting competenceHome nurse visitmaternal post-partum carepostpartum health utilizationBreastfeeding

Outcome Measures

Primary Outcomes (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

    3 years

Secondary Outcomes (6)

  • Adherence to continuity of care guidelines

    3 years

  • Postpartum anxiety

    3 years

  • Breastfeeding duration

    3 years

  • Maternal satisfaction with post-discharge healthcare

    3.5 years

  • Parenting sense of competence

    3.5 years

  • +1 more secondary outcomes

Interventions

Home Nurse VisitBEHAVIORAL

Home nurse visit by maternal child health nurse within first 24-48 after post-partum hospital discharge.

Eligibility Criteria

Age1 Day - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (4)

  • Hackman NM, Schaefer EW, Beiler JS, Rose CM, Paul IM. Breastfeeding outcome comparison by parity. Breastfeed Med. 2015 Apr;10(3):156-62. doi: 10.1089/bfm.2014.0119. Epub 2014 Dec 30.

    PMID: 25549051DERIVED

  • Paul IM, Downs DS, Schaefer EW, Beiler JS, Weisman CS. Postpartum anxiety and maternal-infant health outcomes. Pediatrics. 2013 Apr;131(4):e1218-24. doi: 10.1542/peds.2012-2147. Epub 2013 Mar 4.

    PMID: 23460682DERIVED

  • Bartok CJ, Schaefer EW, Beiler JS, Paul IM. Role of body mass index and gestational weight gain in breastfeeding outcomes. Breastfeed Med. 2012 Dec;7(6):448-56. doi: 10.1089/bfm.2011.0127. Epub 2012 Jun 25.

    PMID: 23215909DERIVED

  • Paul IM, Beiler JS, Schaefer EW, Hollenbeak CS, Alleman N, Sturgis SA, Yu SM, Camacho FT, Weisman CS. A randomized trial of single home nursing visits vs office-based care after nursery/maternity discharge: the Nurses for Infants Through Teaching and Assessment After the Nursery (NITTANY) Study. Arch Pediatr Adolesc Med. 2012 Mar;166(3):263-70. doi: 10.1001/archpediatrics.2011.198. Epub 2011 Nov 7.

    PMID: 22064874DERIVED

Related Links

MeSH Terms

Conditions

HyperbilirubinemiaJaundiceDehydrationDepression, PostpartumBreast Feeding

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersFeeding BehaviorBehavior

Study Officials

  • Ian M Paul, MD, MSc

    Penn State Milton S. Hershey Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 4, 2006

Study Start

September 1, 2006

Primary Completion

August 1, 2009

Study Completion

February 1, 2010

Last Updated

July 28, 2017

Record last verified: 2017-07

Locations

US(2)