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Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates

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ClinicalTrials.gov Identifier: NCT04019886
Recruitment Status : Not yet recruiting
First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University

Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date July 15, 2019
Estimated Study Start Date  ICMJE September 2, 2019
Estimated Primary Completion Date January 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Respiratory Rate (RR) [ Time Frame: Change in RR measured between baseline and 5th day post intervention ]
    RR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)
  • Heart Rate (HR) [ Time Frame: Change in HR measured between baseline and 5th day post intervention ]
    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) [ Time Frame: Change in SPO2 measured between baseline and 5th day post intervention ]
    SPO2 will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)
  • Chest Expansion (CE) [ Time Frame: Change in CE measured between baseline and 5th day post intervention ]
    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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates
Official Title  ICMJE Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates Admitted in Level II Neonatal Intensive Care Unit: A Randomized Controlled Trail
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Neonatal Respiratory Distress Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Other: Neurophysiological Facilitation of Respiration
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 20, 2021
Estimated Primary Completion Date January 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 8 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Asir J Samuel, MPT 8059930222 asirjohnsamuel@mmumullana.org
Contact: Manu Goyal, MPT 8059930229 manu.goyal@mmumullana.org
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019886
Other Study ID Numbers  ICMJE MMDU/IEC/2019/03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Plan to publish in scopus or pubmed journal
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: After ethical approval
Access Criteria: In publically accessible free protocol registration and result system
Responsible Party Asir John Samuel, Maharishi Markendeswar University
Study Sponsor  ICMJE Asir John Samuel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saumya Kothiyal, MPT Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
PRS Account Maharishi Markendeswar University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP