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临床试验/NCT04563364
NCT04563364已完成不适用

Interdisciplinary Hospital-home Intervention on the Adaptation of Motor Development in Premature Children.Randomized Clinical Trial

Universidad de la Sabana1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Motor Development.

研究概览

简要总结

Motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. In Colombia, one out of every five births corresponds to premature babies. In preterm infants requiring hospitalization, early clinical interventions focused on home care have been shown to improve motor development and decrease morbidity.

However, interdisciplinary work, supported by information and communication Technologies (ICT), shows a knowledge gap that can be explored. This leads to the following research question: ¿What is the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions?

Objective: To determine the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions

Methodology Experimental quantitative study with pre-test and post-test to two groups, experimental and control, which compares before and after the intervention. The intervention will be developed in two scenarios: the hospital and the home. The experimental group will receive the intervention and the control group the traditional care established in the institutions for premature children. The calculation of the sample size is 130 participants.

Type of results expected to be obtained It is expected to obtain a supported that justifies the importance of education from hospital stay, post discharge follow-up and parental participation in the adequate stimulation of motor development of the premature. It is expected to incorporate the use of ICT in home monitoring, while implementing the use of a mobile application for this purpose. It is also expected to contribute to the research training of undergraduate and graduate students. In addition, participate in national and international presentations and in the production of scientific articles.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
34 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Premature infants between 34 and 37 weeks of gestation,
  • Infants with weight over 1800gr
  • Hemodynamic stability
  • Interns in NICU of participants institutions (Colombia and Poland).
  • Infants with residence in a places close to the institutional health care services.

排除标准

  • Premature child with a musculoskeletal deformity.
  • Premature child with diagnosis of a genetic syndrome
  • Premature child with congenital heart diseases.
  • Premature child with brain injuries.

结局指标

主要结局

Motor Development.

时间窗: 18 Months

Test on infant motor performance (TIMPSI)

次要结局

  • CapDMP questionnaire(From enrollment to the end of treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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