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临床试验/NCT03146351
NCT03146351已完成不适用

The Effects of Family Centered Physiotherapy Program on Preterm Infants

Gazi University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Motor performance using the Alberta Infant Motor Scale

研究概览

简要总结

Infant born preterm have an increased risk of adverse long-term developmental outcomes.The risk associated with preterm birth increase as gestational age decreases, and vulnerability remains in moderate and early preterm (<34 weeks) and late preterm (>34 weeks). There are many studies in the literature showed that the prevalence of developmental delay increases with premature birth. However, there is no study in the literature investigates effect of early intervention program motor performance in subgroups of preterm infants. Hence the aim of this study is to evaluate the differences in effects of early intervention program on motor development in early and moderate (<34 weeks) and late preterm infants.

详细描述

Fifty-two preterm infants corrected age less than 6 months included in this study. They were separated by their birth weeks. Babies with gestational ages between 34-36 weeks and 6 days (including the given days) are categorized as late preterm, while those born before 34 weeks are grouped as moderate and early preterm. Each group contains 26 infants.

First, sociodemographic information and histories of babies are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking.The Alberta Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. After the detailed examination, intervention program set up for infants. Both groups receive 3 months family based intervention program.

After the intervention program, both groups re-examined.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 6 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Born before 37 gestational weeks,
  • •Accepting to join the study
  • •Corrected age 6 months or less

排除标准

  • •Having high risk factors (e.g. grade 3 or more intraventricular hemorrhage, PVL, serious seizure)
  • •Born after 37 weeks
  • •Corrected age greater than 6 months

研究组 & 干预措施

Early and moderate preterm group

Experimental

Infants born before 34 weeks included in this group

干预措施: Family based early intervention program (NDT-Bobath based) (Other)

Late preterm group

Experimental

Infants born between 34 and 37 weeks included in this group

干预措施: Family based early intervention program (NDT-Bobath based) (Other)

结局指标

主要结局

Motor performance using the Alberta Infant Motor Scale

时间窗: This study is planned to be completed within 6 months

Alberta Infant Motor Scale is used to examine motor performance.

次要结局

未报告次要终点

研究者

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

Murat Fatih KOCYIGIT

Research Assistant

Gazi University

研究点 (1)

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