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临床试验/CTRI/2026/03/106730
CTRI/2026/03/106730尚未招募不适用

Impact of cyclical positioning on total duration of ventilation in pretrem neonates (less than 34 weeks) -a randomised controlled trial

Emilee Das1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年4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
64
试验地点
1

研究概览

简要总结

In my study, in the preinitiation phase, all healthcare professionals will be trained for positioning maneuvers in intubated neonates and those on non invasive ventilation and trained to identify and tackle any adversities associated. We will include neonates less than 34 weeks of gestation and ventilated at inborn or outborn unit for atleast 3 days. Exluded babies will have extreme prematurity (less than 28 weeks of gestation, Persistant pulmonary hypertension of newborn, Babies operated or to be operated on for any surgical cause, Fragile bone disease like osteogenesis imperfecta, Intracranial hemorrhage , birth trauma like fracture bone. We will take consent from parents in the next stage followed by Randomization by computer generated block of size 4 and allocation concealment will be done by serially numbered opaque envelope. We will determine baseline characteristics of enrolled babies and then start the intervention that is protocolised cyclical positioning after 3 days of ventilation. Primary outcome will be total invasive and noninvasive ventilator days and in secondary outcome we will see total number of babies with ventilator associated pneumonia, extubation failure, Duration of nicu stay in days, Duration of only oxygen therapy post weaning, sepsis defined as use of antibiotics post enrollment, intraventricular hemorrhage, pneumothorax and mortality. Then we will do the intention to treat analysis and per protocol analysis.

Our total sample size is 64 and 32 babies in each arm. Aim of my study is to prove that efficacy of protocolised change in position of ventilated neonate will reduce ventilator days significantly . My total study duration is one year and will be conducted in both inborn and outborn unit of LNJP hospital associated with Maulana Azad Medical College.

In previous studies done on preterm neonates, full chest physiotherapy was performed including percussion, vibration along with position change which reduced ventilator days by 7 days. As full physiotherapy is not feasible for every preterm babies we want to do only cyclical position change every 6 hourly that is from supine to right lateral then prone positioning then left lateral and back to supine till baby is off ventilator. We want to show that only this maneuver should reduce ventilator dats by 33 percent of 7 days that is atleast 3 days. Which has not been done in prior studies in literature, hence fulfilling the purpose of my study .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Babies with gestational age of less than 34 weeks , ventilated more than 3 days at our institute anytime before 29 days of age.

排除标准

  • Extreme prematurity (28 days), Babies with Pulmonary artery hypertensiondiagnosed before enrolment, Babies operated or to be operated for any surgical cause, Severe congenital malformation, Fragile bone disease (eg.
  • Osteogenesis imperfecta), Clinical suspicion of Intracranial haemorrhage within 1st 3 days of life , Birth trauma(eg.
  • fracture bone).

研究者

发起方
Emilee Das
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Emilee Das

Maulana Azad Medical College

研究点 (1)

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