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CTRI Number  CTRI/2024/08/072697 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the efficacy of Extended Continuous Positive Airway Pressure in reducing the duration of respiratory support among preterm infants with respiratory problems 
Scientific Title of Study   To assess the efficacy of Extended Continuous Positive Airway Pressure in reducing the duration of respiratory support among preterm infants with respiratory distress syndrome—a pilot randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sathyamoorthy V P 
Designation  DM Student Senior Resident 
Affiliation  JIPMER 
Address  Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8940426923  
Fax    
Email  vpsm96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nishad Plakkal 
Designation  Additional Professor and Head  
Affiliation  JIPMER 
Address  Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7708577133  
Fax    
Email  plakkal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishad Plakkal 
Designation  Additional Professor and Head  
Affiliation  JIPMER 
Address  Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7708577133  
Fax    
Email  plakkal@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research , JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, Pin code 605006 , India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Jawaharlal Institute of Postgraduate Medical Education and Research , JIPMER campus road, Gorimedu, Dhanvantari nagar, Puducherry, 605006 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sathyamoorthy V P  Jawaharlal Institute of Postgraduate Medical Education and Research  Ward Number 6140, Neonatology Division, Department of Neonatology, Women’s and Children’s Hospital (No. 266), JIPMER Campus Road, Gorimedu, Dhanvantari Nagar, Pondicherry, 605006.
Pondicherry
PONDICHERRY 		 8940426923

vpsm96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee,JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Extended CPAP group  Once the stability criteria is reached, CPAP is extended by a minimum of 24 hours, followed by weaning as per standard protocol. Standard weaning protocol is as follows: For infants with gestational age ≤28 weeks or those with FIO2 requirement 0f 22-30% in CPAP will be weaned to HFNC 3L/min with Fio2 upto 30% after discontinuation from CPAP. HFNC flow kept at 3L/min until FI02 requirement comes to 21%. After that HFNC flow will be lowered by 0.5L/min every 1 hr until a flow of 0.5L/min is reached. At this time infants will be seperated from HFNC. For very preterm babies (29+0/7 to 31+6/7weeks) with Fio2 requirement of 21% with CPAP pressure of 6cm H2O will be directly weaned to room air. Hence the total duration of intervention will be 24 hours considering my CPAP extension as the intervention.  
Comparator Agent  Standard weaning protocol group  Once the stability criteria is reached, CPAP discontinued as per standard weaning protocol. Standard weaning protocol is as follows: For infants with gestational age ≤28 weeks or those with FIO2 requirement 0f 22-30% in CPAP will be weaned to HFNC 3L/min with Fio2 upto 30% after discontinuation from CPAP. HFNC flow kept at 3L/min until FI02 requirement comes to 21%. After that HFNC flow will be lowered by 0.5L/min every 1 hr until a flow of 0.5L/min is reached. At this time infants will be seperated from HFNC. For very preterm babies (29+0/7 to 31+6/7weeks) with Fio2 requirement of 21% with CPAP pressure of 6cm H2O will be directly weaned to room air 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Gestational age less than 32 weeks treated for respiratory distress syndrome with or without surfactant and meeting the predesignated CPAP stability criteria will be included.  
 
ExclusionCriteria 
Details  major congenital anomalies, clinical suspicion of congenital pneumonia.

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time to wean off initial respiratory support to room air.  1. Baseline (start of intervention)
2. Every 24 hours
3. Specific days (day 3,7,14)
4. At each weaning attempt
5. At successful weaning(24 hours off support)
6. Follow up at 24, 48 hours and 7 days after weaning 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of bronchopulmonary dysplasia: The study will measure the incidence of bronchopulmonary dysplasia among participants  This is assessed at 36 weeks postmenstrual age 
Neonatal mortality : the rate of death among neonates in the study.  This is assessed during initial hospital stay & up to 28 days of life. 
Length of hospital stay: The duration of hospitalization from birth until discharge.  This is assessed from birth until first discharge from the hospital. 
Time to full feeds: The period required for participants to achieve full enteral feeding.  This is assessed daily from birth until full enteral feeding is achieved. 
Time to establish full oral feeding (paladai feeds or breastfeeds, off gavage feeds for more than 48 hours): The time taken to transition to & maintain full oral feeding.  This is assessed daily from birth until oral feeding is established 
Re-initiation of respiratory support after weaning to room air: The frequency of restarting respiratory support after initial successful weaning to room air.
 		 This is assessed from weaning to room air until first discharge from hospital. 
Re-intubation during the first week of life: The incidence of re-intubation within the first seven days after birth.  This is assessed within the first 7 days of life. 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This randomised controlled trial evaluates the efficacy of extended CPAP in preterm infants with respiratory distress syndrome. Infants are stratified by gestational age and randomised into two groups: one receiving extended CPAP for an additional 24 hours and the other weaned based on unit protocols. The primary outcome is the time to wean off CPAP to room air. Secondary outcomes include bronchopulmonary dysplasia , neonatal mortality, length of hospital stay , time to full and oral feeding, re initiation of respiratory support, and re intubation in the first week. This open-label study aims to optimise CPAP duration and improve clinical outcomes.  
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