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Clinical Trials/NCT02041923
NCT02041923
Completed
Not Applicable

Feeding and Transition to Home for Preterms at Social Risk

University of Illinois at Chicago2 sites in 1 country198 target enrollmentJanuary 2007
ConditionsPremature Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
University of Illinois at Chicago
Enrollment
198
Locations
2
Primary Endpoint
Infant Behavioral Organization
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Premature infants are at high risk of suboptimal health and development. This randomized clinical trial evaluated the impact of a developmentally based intervention, H-HOPE (Hospital-home transition: optimizing prematures' environment), for infants born between 29-34 weeks gestational age (GA) with at least two social-environmental risk factors. H-HOPE will improve infant behavior, mother care for the infants, mother-infant interaction and will reduce health care costs.

Detailed Description

Premature infants are at high risk of suboptimal health and development. This randomized clinical trial evaluated the impact of a developmentally based intervention, H-HOPE (Hospital-home transition: optimizing prematures' environment), for infants born between 29-34 weeks gestational age (GA) with at least two social-environmental risk factors. H-HOPE is innovative because it integrates two components used successfully in prior research but never before combined. Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants. The synergistic effect of these simultaneous improvements for infant and mother should lead to: 1) more mature infant behavioral organization and hospital progression; 2) improved maternal recognition of infant behavioral cues, greater confidence in infant care, more positive perception of the infant, and lower anxiety; 3) more positive mother-infant interaction and greater mother-infant contingency; 4) improved infant development and growth; and 5) lower infant health care utilization and costs. H-HOPE provides intervention from 32 weeks GA to one month corrected age, a time of transition to oral feeding, from the hospital to home, and from hospital to outpatient providers, when mothers of premature infants express need for support. We will randomly assign 252 infants to the H-HOPE or the Attention Control group. Power analysis shows that with an 80% retention rate, we will have adequate power to identify expected intervention effects. Variables are measured during hospital stay, at intake, immediately prior to discharge, and at six weeks corrected age. Analyses employ Hierarchical Linear Modeling clustered within clinical sites, with infant sex, biologic and social-environmental risk factors as covariates. If successful, H-HOPE will provide a national model for improving early infant health and development and reducing health costs. For example, reducing hospital stays by just three days for the almost 500,000 infants born prematurely could save over two billion dollars annually.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
June 2013
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rosemary White-Traut

Professor (retired)

University of Illinois at Chicago

Eligibility Criteria

Inclusion Criteria

  • 29-34 weeks gestation at birth
  • no other major health problems
  • mothers have at least 2 socio-environmental risk factors such as African American or Latina
  • Less then high school education
  • history of mental illness
  • less than 150% poverty level
  • 2 children less than 24 months old
  • 4 or more children living in the home
  • living in a disadvantaged neighborhood

Exclusion Criteria

  • Infant has congenital anomaly
  • Necrotizing enterocolitis
  • Brain injury
  • chronic lung disease
  • prenatal drug exposure
  • mother is an illicit drug user
  • mother is not the legal guardian

Outcomes

Primary Outcomes

Infant Behavioral Organization

Time Frame: From birth to 36 weeks

Orally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week.

Mother-Infant Interaction

Time Frame: 34 - 44 weeks postmenstrual age

Mother-infant interaction during feeding measured via the Nursing Child Assessment Feeding Scale (NCAFS). The NCAFS possible scores ranged from 0-76. A higher score indicates a better outcome.

Secondary Outcomes

  • Health Care Utilization(Illness visits within 6 weeks post hospital discharge)
  • Infant Growth(from birth to hospital discharge, up to 9 weeks)

Study Sites (2)

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