Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates

Neonatal Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04019886
• Other study ID #: MMDU/IEC/2019/03
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: January 20, 2021

Study information

• Verified date: March 2020
• Source: Maharishi Markendeswar University
• Contact: Asir J Samuel, MPT
• Phone: 8059930222
• Email: asirjohnsamuel[@]mmumullana.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 20, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Days

Eligibility

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

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Neonatal Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
India	Neonatal Intensive Care Unit	Ambala	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Asir John Samuel

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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