Clinical trial NCT04019886: Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates
Official title: Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates Admitted in Level II Neonatal Intensive Care Unit: A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Respiratory Distress Syndrome
Keywords: Preterm
Neonates
Neurofacilitation Technique
Respiration
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Outcome measures will be taken on the first day prior to the intervention and on the 5th day after the intervention. Outcome measure used will be Respiratory Rate, Heart Rate, Saturation of Peripheral Oxygen (SPO2) and chest expansion to see the improvement in the patient.

Interventions - In experimental group - PNF respiration will be given to the neonate in supine position.

In control group - No intervention will be given in control group. Outcome measure will be measured at baseline after 5 days.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Respiratory Rate (RR)
timeFrame: Change in RR measured between baseline and 5th day post intervention
measure: Heart Rate (HR)
timeFrame: Change in HR measured between baseline and 5th day post intervention
measure: Saturation of Peripheral Oxygen (SPO2)
timeFrame: Change in SPO2 measured between baseline and 5th day post intervention
measure: Chest Expansion (CE)
timeFrame: Change in CE measured between baseline and 5th day post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ambala
country: India
facility: Neonatal Intensive Care Unit
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
name: Saumya Kothiyal, MPT
role: PRINCIPAL_INVESTIGATOR
References: