Feeding and Transition to Home for Preterms at Social Risk
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Intervention name(s): H-HOPE; Attention Control
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.
Other intervention name(s): ATVV Intervention; Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: preterm infant; stable infant; mother-infant interaction; health care cost; H-HOPE intervention; mother outcomes; infant behavioral organization; infant growth