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Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates

Primary Purpose

Neonatal Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Neurophysiological Facilitation of Respiration
Sponsored by
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Respiratory Distress Syndrome focused on measuring Preterm, Neonates, Neurofacilitation Technique, Respiration

Eligibility Criteria

1 Day - 8 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neonatal Intensive Care Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Respiratory Rate (RR)
RR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after 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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
March 6, 2020
Sponsor
Asir John Samuel
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1. Study Identification

Unique Protocol Identification Number
NCT04019886
Brief Title
Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates
Official Title
Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates Admitted in Level II Neonatal Intensive Care Unit: A Randomized Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2, 2020 (Anticipated)
Primary Completion Date
January 5, 2021 (Anticipated)
Study Completion Date
January 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Distress Syndrome
Keywords
Preterm, Neonates, Neurofacilitation Technique, Respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
It consists following techniques- Peri-oral stimulation Vertebral pressure Anterior stretch -lifting posterior basal area Co-contraction -abdomen Intercoastal stretch Moderate manual pressure
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Outcome measure will be measured at baseline on first day prior to the intervention and on 5th day after the treatment.
Intervention Type
Other
Intervention Name(s)
Neurophysiological Facilitation of Respiration
Intervention 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.
Primary Outcome Measure Information:
Title
Respiratory Rate (RR)
Description
RR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)
Time Frame
Change in RR measured between baseline and 5th day post intervention
Title
Heart Rate (HR)
Description
HR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)
Time Frame
Change in HR measured between baseline and 5th day post intervention
Title
Saturation of Peripheral Oxygen (SPO2)
Description
SPO2 will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)
Time Frame
Change in SPO2 measured between baseline and 5th day post intervention
Title
Chest Expansion (CE)
Description
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)
Time Frame
Change in CE measured between baseline and 5th day post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
8 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asir J Samuel, MPT
Phone
8059930222
Email
asirjohnsamuel@mmumullana.org
First Name & Middle Initial & Last Name or Official Title & Degree
Manu Goyal, MPT
Phone
8059930229
Email
manu.goyal@mmumullana.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saumya Kothiyal, MPT
Organizational Affiliation
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Unit
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asir J Samuel, MPT
Phone
8059930222
Email
asirjohnsamuel@mmumullana.org
First Name & Middle Initial & Last Name & Degree
Manu Goyal, MPT
Phone
805993029
Email
manu.goyal@mmumullana.org
First Name & Middle Initial & Last Name & Degree
Saumya Kothiyal, MPT

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates

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