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临床试验/CTRI/2025/01/079300
CTRI/2025/01/079300尚未招募不适用

Effectiveness of Premature Infant Oral Motor Intervention on oral feeding readiness among preterm neonates-A randomized controlled trial

Meenu Chandran J1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To determine the efficacy of Premature Infant Oral Motor Intervention on oral feeding readiness among preterm neonates

研究概览

简要总结

Title

Efficacy of Premature Infant Oral Motor Intervention on Oral feeding readiness among preterm neonates – A randomized controlled trial

Objective of the study

=  To determine the efficacy of Premature Infant Oral Motor Intervention (PIOMI) on oral feeding readiness among preterm neonates admitted in Neonatal Intensive Care Unit.

FoFormal permission for data collection will be obtained from Institutional Research Committee, Institutional Ethics committee, Medical Superintendent SAT Hospital Thiruvananthapuram and Head of the department, Neonatology. After getting informed consent from the parents investigator will select preterm neonates admitted in NICU who meet the eligibility criteria for the study and will be randomly allocated in to experimental and control group. The samples will be allocated equally by using block randomization with fixed block size of 4 in to two groups, experimental and control group. The preterm neonates in the experimental group will receive PIOMI for 15 minutes before the gavage feed, along with the routine nursing care 2 times daily using aseptic precautions. This process will be continued for maximum 14 days, when the baby reaches feeding readiness whichever is earlier. The control group will also receive routine care during the 14 days of the study. Both groups will be assessed from the 4th day onwards till the achievement of oral feeding readiness. (POFRAS score >30)

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
7.00 Month(s) 至 8.00 Month(s)(—)
性别
All

入选标准

  • Preterm neonates born between 29 to 32 weeks of gestation Preterm neonates who are haemodynamically stable.

排除标准

  • Neuromuscular disorder Chromosomal anomaly Craniofacial malformmation.

结局指标

主要结局

To determine the efficacy of Premature Infant Oral Motor Intervention on oral feeding readiness among preterm neonates

时间窗: The outcome will be assessed 7th and 14th day of the study

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Meenu Chandran J
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Meenu Chandran J

Government College of Nursing Thiruvananthapuram

研究点 (1)

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