Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates

NCT04019886 | Unknown DMC

• 1 other identifier: MMDU/IEC/2019/03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Respiratory Distress Syndrome

Keywords

Preterm; Neonates; Neurofacilitation Technique; Respiration

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

It consists following techniques- 1. Peri-oral stimulation 2. Vertebral pressure 3. Anterior stretch -lifting posterior basal area 4. Co-contraction -abdomen 5. Intercoastal stretch 6. Moderate manual pressure

Other: Neurophysiological Facilitation of Respiration

Control Group

NO INTERVENTION

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

Interventions

Neurophysiological Facilitation of Respiration OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 1 Day - 8 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asir John Samuel: lead

Study Sites (1)

Neonatal Intensive Care Unit

Ambāla, Haryana, 133207, India

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saumya Kothiyal, MPT

  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asir J Samuel, MPT

CONTACT

8059930222; asirjohnsamuel@mmumullana.org

Manu Goyal, MPT

CONTACT

8059930229; manu.goyal@mmumullana.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 15, 2019
• Study Start: September 2, 2020
• Primary Completion: January 5, 2021
• Study Completion: January 20, 2021
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After ethical approval
• Access Criteria: In publically accessible free protocol registration and result system

Locations

IN (1)