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临床试验/CTRI/2024/03/064061
CTRI/2024/03/064061尚未招募1/2 期

Effect of multisensory stimulation on neurobehavioral response and weight gain in preterm infants

Ayisha Nazarin T1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年3月18日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Neurobehavioral Response and Weight Gain

研究概览

简要总结

EFFECT OF MULTISENSORY STIMULATION ON NEUROBEHAVIORAL RESPONSE AND WEIGHT GAIN IN PRETERM INFANTS

ABSTRACT

INTRODUCTION:

Premature infants undergo a lot of stressful procedures during care and treatment procedures, which may lead to weight changes and a lack of sensory experiences that are vital for normal brain development. They are also exposed to excessive or inappropriately timed stimulation in the NICU that leads to deleterious effects on premature infants whose brains are immaturely developed.

AIM:

This study aims to evaluate multisensory stimulation in stimulating respective sensory receptors for weight gain and neurobehavioral response in preterm infants.

METHOD:

The study will have two groups:  control group received routine medical and nursery care in the NICU whereas intervention group received the same programme given to the control group in addition to multisensory stimulation programme for a 45-minute daily session, for 3 consecutive weeks. Twenty preterm infants admitted to the NICU who meet the inclusion criteria will be selected. Eligible infants will be randomly assigned to one of the two groups, The outcomes are neurobehavioral response and weight gain, which will be measured before and after the intervention by a Morgan neonatal neurobehavioral examination and a digital weighing scale, respectively.

RESULT:

Statistical analysis will be done after data collection and conclusion will be drawn

KEY WORDS:

Preterm infants, Multisensory stimulation, Neurobehavior, Weight gain

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
7.00 Month(s) 至 8.00 Month(s)(—)

入选标准

  • Infants born at 32-36 weeks of gestational age Gender both male and female are included Weight 1300g – 1700g APGAR score at 5 minutes scores above 6 Infants fed orally by gavage Babies who were hemodynamically stable Infants with normal visual and auditory status Infants with written consent of their parent.

排除标准

  • Congenital malformation Genetic or metabolic diseases Seizure disorder CNS injuries Severe asphyxia High level of bilirubin Respiratory diseases Infants with the need for mechanical ventilation.
  • Infant who takes breastfeed.

结局指标

主要结局

Neurobehavioral Response and Weight Gain

时间窗: At baseline and after 3 weeks

次要结局

未报告次要终点

研究者

发起方
Ayisha Nazarin T
申办方类型
Other [Self ( Part Of Master Programme)]
责任方
Principal Investigator
主要研究者

Ayisha Nazarin T

Sri Ramakrishna Institute of Paramedical Sciences

研究点 (1)

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