Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates

NCT ID: NCT04019886

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2021-01-20

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.

Conditions

Neonatal Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

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

Group Type: EXPERIMENTAL

Neurophysiological Facilitation of Respiration

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 8 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asir John Samuel

OTHER

Sponsor Role: lead

Responsible Party

Asir John Samuel

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Saumya Kothiyal, MPT

Role: PRINCIPAL_INVESTIGATOR

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Locations

Neonatal Intensive Care Unit

Ambāla, Haryana, India

Countries

India

Central Contacts

Asir J Samuel, MPT

Role: CONTACT

asirjohnsamuel@mmumullana.org

8059930222

Manu Goyal, MPT

Role: CONTACT

manu.goyal@mmumullana.org

8059930229

Facility Contacts

Asir J Samuel, MPT

Role: primary

asirjohnsamuel@mmumullana.org

8059930222

Manu Goyal, MPT

Role: backup

manu.goyal@mmumullana.org

805993029

Other Identifiers

MMDU/IEC/2019/03

Identifier Type: -

Identifier Source: org_study_id