Neonatal Respiratory Distress SyndromeNCT04019886
Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates
A study testing Neurophysiological Facilitation of Respiration in people with Neonatal Respiratory Distress Syndrome, run by Asir John Samuel at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 8 days
- Conditions the study is for
- Neonatal Respiratory Distress Syndrome
- What is being tested?
- Neurophysiological Facilitation of Respiration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 2 Sep 2020to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 8 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates within eight days of birth Neonates born before 37 weeks of gestation Neonates diagnosed with Respiratory distress syndrome
Who cannot join
- Medically unstable neonates Neonates who undergone recent surgery or congenital disorder
Trial locations and contacts
1 site in 1 country.
India1 site
Neonatal Intensive Care Unit
Ambāla, Haryana, 133207
Asir J Samuel, MPT, 8059930222, asirjohnsamuel@mmumullana.org
Manu Goyal, MPT, 805993029, manu.goyal@mmumullana.org
About this study
Official title: Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates Admitted in Level II Neonatal Intensive Care Unit: A Randomized Controlled Trail
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.
Read the 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.
- Conditions
- Neonatal Respiratory Distress Syndrome
- Being tested
- Neurophysiological Facilitation of Respiration
- Keywords
- Preterm, Neonates, Neurofacilitation Technique, Respiration
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurophysiological Facilitation of RespirationOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate (RR)
RR will be assessed from the monitor display (On 1st day prior to intervention and on the 5th day after intervention)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change in CE measured between baseline and 5th day post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start2 Sep 2020 (estimated)
- Primary completion5 Jan 2021 (estimated)
- Study completion20 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Saumya Kothiyal, MPT, Principal investigator, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019886
- Sponsor's protocol ID
- MMDU/IEC/2019/03
- Status last verified
- Mar 2020
- First submitted
- 2 Jul 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to publish in scopus or pubmed journal
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates Admitted in Level II Neonatal Intensive Care Unit: A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT04019886
- Acronym / sponsor ID
- MMDU/IEC/2019/03
- Conditions
- Neonatal Respiratory Distress Syndrome
- Keywords
- Preterm, Neonates, Neurofacilitation Technique, Respiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 2 Sep 2020 (estimated)
- Primary completion
- 5 Jan 2021 (estimated)
- Study completion
- 20 Jan 2021 (estimated)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Neurophysiological Facilitation of RespirationIt 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 |
| 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. |
Who may qualify
- Ages
- 1 day to 8 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates within eight days of birth Neonates born before 37 weeks of gestation Neonates diagnosed with Respiratory distress syndrome
Key exclusion criteria (1 listed)
- Medically unstable neonates Neonates who undergone recent surgery or congenital disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurophysiological Facilitation of RespirationSix neuro-facilitation techniques will be given to experimental group. Each technique will be given for 5 seconds hold with 5 repetitions and two sets. | Other | Experimental Group |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Yes. Plan to publish in scopus or pubmed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saumya Kothiyal, MPT principal investigator
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurophysiological Facilitation of Respiration in people with Neonatal Respiratory Distress Syndrome, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asir J Samuel, MPT (8059930222, asirjohnsamuel@mmumullana.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate (RR) (time frame: Change in RR measured between baseline and 5th day post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.