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临床试验/NCT04800328
NCT04800328已完成不适用

Reliability of Infant Neurological International Battery (INFANIB) Among Hospitalized Preterm Infants.

Asir John Samuel1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
INFANIB score

研究概览

简要总结

Reliability of infant neurological international battery (INFANIB) among hospitalized preterm infants will be checked. This study will mainly focus on test-retest reliability.

详细描述

Background: NICU is a specialised intensive care unit that treats and cares for premature or critically ill newborn babies. A special category of high-risk babies consists of premature infants. Their motor growth differs from that of healthy full-term infants and their occurrence of motor disorders is greater. The outcome of neuromotor disorders can be substantially changed by treatments during the first year of life. So in order to detect these neuromotor disorder there must be a reliable screening tool present. Hence, in this study we will check reliability of INFANIB.

Purpose: Reliability of INFANIB among hospitalized preterm infants. Methodology: It will be an observational study and will be carried out in Neonatal Intensive Care Unit (NICU). The study will recruit preterm infants that are stable and are present without any respiratory assistive devices.

INFANIB screening tool will be performed on these infants. It has 20 items that measure the state of the infant for body tone and posture, primitive reflexes and French angles in the supine, prone, sitting, standing and suspended position upto 18 months. But we will take only preterm infants so only 14 items will be assessed and infants will be scored accordingly. The main focus will be on test- retest reliability.

Discussion: A similar research has been carried out in Iran and China, that established that reliability of INFANIB is excellent. Another research was carried out in India that stated INFANIB's reliability to be low. So this study is required to be carried out in India to know the actual results.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm neonates.
  • Stable neonates.

排除标准

  • Unstable neonates.
  • Neonates on respiratory assistive devices.

结局指标

主要结局

INFANIB score

时间窗: Change from score of INFANIB scale at three consecutive days.

Measuring neurodevelopmental maturity among neonates

次要结局

未报告次要终点

研究者

发起方
Asir John Samuel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Asir John Samuel

Associate Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Maharishi Markendeswar University (Deemed to be University)

研究点 (1)

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