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临床试验/NCT04019886
NCT04019886Unknown不适用

Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates Admitted in Level II Neonatal Intensive Care Unit: A Randomized Controlled Trail

Asir John Samuel2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Heart Rate (HR)

研究概览

简要总结

Background: Respiratory distress syndrome (RDS) or Neonatal respiratory distress syndrome (NRDS) is characterized by pulmonary insufficiency, in preterm neonates and is the major cause of death in preterm. Neurophysiological facilitation of Respiration (NFR) technique produce reflex respiratory movement response, as it involves application of external proprioceptive and tactile stimuli that is known to alter the rate and depth of breathing Aim: This study is being conducted to determine the effectiveness of NFR in preterm neonates diagnosed with RDS.

Methods: In this study 30 preterm (1- 8 days) neonates diagnosed with Respiratory Distress Syndrome will be taken and assigned into two groups,Experimental group (n=15) and control group (n=15). Neonates within eight days of birth those born before 37 weeks of gestation, diagnosed with RDS were included in the study. Neonate undergone recent surgery or congenital disorder, or medically unstable will be excluded.

Data analysis: Normality of the collected data will be analyzed with either two of the normality test i.e. Shapiro Wilk test and Kolmogorov Smirnov test based on sample size. Demographics characteristic of collected sample will be expressed in a mean standard deviation or median and range based normality. For Between group comparison Independent t test or Mann Whitney U test and for within group comparison paired t test or Wilcoxon singed ranked test will be used.

详细描述

  1. Introduction:

Respiratory distress syndrome (RDS) or Neonatal respiratory distress syndrome (NRDS) is characterized by pulmonary insufficiency, in preterm neonates and is the major cause of death in preterm. The major cause of RDS is surfactant deficiency. Main features of respiratory distress syndrome are retraction, grunting and tachypnoea and sometimes cyanosis is also present as an associated sign.There are various types of Physiotherapy Interventions given for respiratory disorders in neonates, namely they are chest percussion, vibration and shaking, postural drainage (gravity assisted), Neurophysiological Facilitation of Respiration (NFR). NFR technique produce reflex respiratory movement response, as it involves application of external proprioceptive and tactile stimuli that is known to alter the rate and depth of breathing.

1.1Problem statement: Role of pulmonary NFR has shown to be effective in adult patients with COPD and in geriatric population. This study aims to evaluate the effectiveness of NFR in neonates with respiratory conditions.

1.2 Objective of the study: To demonstrate the benefit of NFR in hospitalised neonates with Respiratory Distress Syndrome (RDS). 2. Procedure:

Participants will be selected by simple random sampling method according to the selection criteria.Procedure will be explained to the patient and written consent will be taken from them.

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
Single (Participant)

入排标准

年龄范围
1 Day 至 8 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates within eight days of birth Neonates born before 37 weeks of gestation Neonates diagnosed with Respiratory distress syndrome

排除标准

  • Medically unstable neonates Neonates who undergone recent surgery or congenital disorder

结局指标

主要结局

Heart Rate (HR)

时间窗: Change in HR measured between baseline and 5th day post intervention

HR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)

Respiratory Rate (RR)

时间窗: Change in RR measured between baseline and 5th day post intervention

RR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)

Saturation of Peripheral Oxygen (SPO2)

时间窗: Change in SPO2 measured between baseline and 5th day post intervention

SPO2 will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)

Chest Expansion (CE)

时间窗: Change in CE measured between baseline and 5th day post intervention

CE will be measured with the help of measuring tape at nipple level (On 1st day prior to intervention and on the 5th day after intervention)

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 Markendeswar University (Deemed to be University)

研究点 (2)

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