Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates

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

Sponsors

Lead Sponsor: Asir John Samuel

Source Maharishi Markendeswar University (Deemed to be University)
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.

Overall Status Not yet recruiting
Start Date September 2, 2020
Completion Date January 20, 2021
Primary Completion Date January 5, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Respiratory Rate (RR) Change in RR measured between baseline and 5th day post intervention
Heart Rate (HR) Change in HR measured between baseline and 5th day post intervention
Saturation of Peripheral Oxygen (SPO2) Change in SPO2 measured between baseline and 5th day post intervention
Chest Expansion (CE) Change in CE measured between baseline and 5th day post intervention
Enrollment 30
Condition
Intervention

Intervention Type: Other

Intervention Name: Neurophysiological Facilitation of Respiration

Description: Six neuro-facilitation techniques will be given to experimental group. Each technique will be given for 5 seconds hold with 5 repetitions and two sets.

Arm Group Label: Experimental Group

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

Gender: All

Minimum Age: N/A

Maximum Age: 8 Days

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Saumya Kothiyal, MPT Principal Investigator Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Overall Contact

Last Name: Asir J Samuel, MPT

Phone: 8059930222

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: Neonatal Intensive Care Unit Asir J Samuel, MPT 8059930222 [email protected] Saumya Kothiyal, MPT Principal Investigator
Location Countries

India

Verification Date

March 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Maharishi Markendeswar University (Deemed to be University)

Investigator Full Name: Asir John Samuel

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental Group

Type: Experimental

Description: It consists following techniques- Peri-oral stimulation Vertebral pressure Anterior stretch -lifting posterior basal area Co-contraction -abdomen Intercoastal stretch Moderate manual pressure

Label: Control Group

Type: No Intervention

Description: Outcome measure will be measured at baseline on first day prior to the intervention and on 5th day after the treatment.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov