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

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.

Study Overview

• Status: Unknown
• Conditions: Neonatal Respiratory Distress Syndrome
• Intervention / Treatment: Other: Neurophysiological Facilitation of Respiration

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Ambala, Haryana, India, 133207
      • Neonatal Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; It consists following techniques-; Peri-oral stimulation; Vertebral pressure; Anterior stretch -lifting posterior basal area; Co-contraction -abdomen; Intercoastal stretch; Moderate manual pressure	Other: Neurophysiological Facilitation of Respiration; 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.
No Intervention: Control Group; Outcome measure will be measured at baseline on first day prior to the intervention and on 5th day after the treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Rate (RR)	RR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)	Change in RR measured between baseline and 5th day post intervention
Heart Rate (HR)	HR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)	Change in HR measured between baseline and 5th day post intervention
Saturation of Peripheral Oxygen (SPO2)	SPO2 will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)	Change in SPO2 measured between baseline and 5th day post intervention
Chest Expansion (CE)	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)	Change in CE measured between baseline and 5th day post intervention

Collaborators and Investigators

• Sponsor: Asir John Samuel
• Investigators: Principal Investigator: Saumya Kothiyal, MPT, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Anticipated): September 2, 2020
• Primary Completion (Anticipated): January 5, 2021
• Study Completion (Anticipated): January 20, 2021

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Neonates; Respiration; Preterm; Neurofacilitation Technique
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease
• Other Study ID Numbers: MMDU/IEC/2019/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Plan to publish in scopus or pubmed journal
• IPD Sharing Time Frame: After ethical approval
• IPD Sharing Access Criteria: In publically accessible free protocol registration and result system
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No