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临床试验/NCT00173108
NCT00173108已完成不适用

Early Intervention for Preterm Infants

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2006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
240
试验地点
2
主要终点
Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan.

研究概览

简要总结

The first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at clinic and home. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age. The clinical feasibility and usefulness of implementing these intervention programs within the context of randomized intervention study subject to the existing constraints of the hospital and home settings will be tested in a pilot study.

The second aim is to conduct a randomized control trial to examine the costs and effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and socio-economically matched normal full-term infants will also be included as a comparison group. Outcome measures that include child, parenting, and transactions outcomes will be compared between groups. Child outcome measures will include health status, growth, neurodevelopment, and neurosensory status; parenting outcome measures will include maternal parenting competence, social support, and psychological stress; transactions outcome measure will be mother-infant interaction. Costs (direct and indirect costs) associated with each early intervention program during the follow-up period will be estimated. Average and incremental cost/effectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants.

详细描述

Preterm birth with very low birth weight (VLBW) (gestational age <37 weeks and birth weight <1,501 g) is a significant public health problem worldwide. Longitudinal follow-up studies showed that VLBW preterm infants require prolonged hospitalization and are at substantial risk for various morbidities during neonatal period than those born at normal birth weight. Furthermore, approximately 40% of VLBW preterm infants are burden with adverse outcomes from chronic health problems and re-hospitalizations, to lower IQ, developmental delays, behavioral problems, and poor educational achievement. Accumulating data collected in Western developed countries have suggested that comprehensive and intensive early interventions may be beneficial for preterm infants and their families. However, there is little information concerning what early intervention should be attempted for these infants and their families in Taiwan. The purpose of this study is therefore to examine the cost-effectiveness of three early intervention programs i.e., the usual care program, the clinic-based intervention program, and the home-based intervention program for VLBW preterm infants. In a preliminary study, we surveyed the need of intervention services following hospital discharge in VLBW preterm infants (N=69) and their families. All mothers expressed the need of services that 60 (87%) preferred service delivery at home and 9 (13%) preferred service delivery at neonatal follow-up clinic. The intervention services specifically identified were health and respiratory assistance (N=22), feeding assistance (N=17), education of child development skills (N=12), and parent support (N=8). Based on these survey data and the results of previous intervention studies, we will develop in this proposed research project a clinic-based intervention program and a home-based intervention program that have common intervention services but are respectively delivered via clinic visit and home visit. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age.

This will be a four-year research project that employs a single blind, randomized experimental design to examine the efficacy of the early intervention programs for VLBW preterm infants. For the first year, we will develop the clinic-based intervention program and the home-based intervention programs in the actual situations to examine their clinical usefulness. From the second to the fourth year, 180 VLBW preterm infants who are born and admitted to the neonatal intensive care units of National Taiwan University Hospital and MacKay Memorial Hospital will be randomly assigned to the usual care program, the clinic-based intervention program, and the home-based intervention program. Sixty gender and socio-economically matched normal full-term infants will also be included as a comparison group. Child, parenting, and transactions outcomes will be assessed when infants are at 4, 6, 12, 18, and 24 months of corrected age. Child outcomes are measured by health status, growth, neurodevelopment, and neurosensory status; parenting outcomes are measured by maternal parenting competence, social support, and psychological stress; transactions outcome is measured by mother-infant interaction. Generalized estimating equations will be used to examine the differences in changes of outcome variables between intervention and control groups. At the end of the fourth year, the costs and effectiveness of the three intervention programs will be compared to determine which one is more cost-effective for VLBW preterm infants in Taiwan. The results of this study will help clinicians and parents understand the efficacy of early intervention for VLBW preterm infants. Furthermore, the data of this study will provide important information to policy makers and health administrators concerning resource allocation of early intervention forVLBW preterm infants in Taiwan.

研究设计

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

入排标准

年龄范围
— 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan.

时间窗: In-hospital, 6, 12, 18 and 24 months of age

Effectiveness includes the child (health, growth, neurodevelopment, and neurosensory), parent (competence, social support, and psychological stress) and transaction outcomes (parent-child interaction). Cost includes direct and indirect cost related to health and intervention program

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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