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Trial record 10 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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

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.


Condition or disease Intervention/treatment Phase
Neonatal Respiratory Distress Syndrome Other: Neurophysiological Facilitation of Respiration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates Admitted in Level II Neonatal Intensive Care Unit: A Randomized Controlled Trail
Estimated Study Start Date : September 2, 2019
Estimated Primary Completion Date : January 5, 2021
Estimated Study Completion Date : January 20, 2021


Arm Intervention/treatment
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
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.

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.



Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)



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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019886


Contacts
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Contact: Asir J Samuel, MPT 8059930222 asirjohnsamuel@mmumullana.org
Contact: Manu Goyal, MPT 8059930229 manu.goyal@mmumullana.org

Locations
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India
Neonatal Intensive Care Unit Not yet recruiting
Ambala, Haryana, India, 133207
Contact: Asir J Samuel, MPT    8059930222    asirjohnsamuel@mmumullana.org   
Contact: Manu Goyal, MPT    805993029    manu.goyal@mmumullana.org   
Principal Investigator: Saumya Kothiyal, MPT         
Sponsors and Collaborators
Asir John Samuel
Investigators
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Principal Investigator: Saumya Kothiyal, MPT Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

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Responsible Party: Asir John Samuel, Associate Professor, Maharishi Markendeswar University
ClinicalTrials.gov Identifier: NCT04019886     History of Changes
Other Study ID Numbers: MMDU/IEC/2019/03
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to publish in scopus or pubmed journal
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After ethical approval
Access Criteria: In publically accessible free protocol registration and result system

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University:
Preterm
Neonates
Neurofacilitation Technique
Respiration
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases