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临床试验/NCT02041923
NCT02041923已完成不适用

Feeding and Transition to Home for Preterms at Social Risk

University of Illinois at Chicago4 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
198
试验地点
4
主要终点
Infant Behavioral Organization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
2 Hours 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Infant Behavioral Organization

时间窗: 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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosemary White-Traut

Professor (retired)

University of Illinois at Chicago

研究点 (4)

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