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CTRI Number  CTRI/2012/12/003241 [Registered on: 19/12/2012] Trial Registered Retrospectively
Last Modified On: 19/12/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [non invasive ventilation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Non invasive ventilation strategies in preterm neonates 
Scientific Title of Study   Comparison of non invasive modalities -nasal intermittent positive pressure ventilation and nasal continuous positive pressure ventilation in preterm neonates - RCT 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tisha 
Designation  Assistant Professor (Respiratory Therapist) 
Affiliation  Manipal College of Allied Health Science 
Address  Department of Respiratory Therapy Manipal College of Allied Health Science Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  09008765696  
Fax    
Email  sweetjunks@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Leslie Lewis 
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Head of Neonatal Unit Department of Pediatrics Kasturba Medical College Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  09449208476  
Fax    
Email  leslielewis1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Leslie Lewis 
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Head of Neonatal Unit Department of Pediatrics Kasturba Medical College Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  09449208476  
Fax    
Email  leslielewis1@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 
Tisha Ann Skariah  Neonatal Intensive Care Unit (NICU)Kasturba hospital, Manipal  NICU Kasturba Hospital Manipal Udupi
Udupi
KARNATAKA 		 09008765696

sweetjunks@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Manipal, Udupi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Neonates with respiratory distress,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NCPAP  NCPAP in preterm neonates are administered after randomization to compare their outcomes- PEEP- 4-6cmH2O FiO2- 21- 50% primary outcome was assessed during first 48 hrs 
Intervention  NIPPV/NIMV  NIPPV was administered after randomization. ventilatory parameters were- PIP- 10-20cmH2O. PEEP- 4-6cmH2O FiO2- 21- 50% rate- 20-40bpm primary outcome was assessed during first 48 hrs  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All preterm and late preterm neonates (<37 weeks) with Downe’s score ≥3.
Age limit is 0- 28 days of life 
 
ExclusionCriteria 
Details  1. Neonates with congenital cyanotic heart disease.
2. Neonates with major congenital malformations.
3. Neonates with air leak syndromes.

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is ‘failure’ of noninvasive respiratory support, and necessitating intubation and mechanical ventilation within 48 hours of initiation of non invasive ventilator support.  TIME LIMIT IS 48 Hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1. duration of respiratory support
2.duration of NICU stay
3.days to reach full feed ,  		 during full stay at NICU
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   12/10/2011 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The preterm neonates with respiratory distress are being randomized and allocated the intervention after obtaining consent from parents. 100 neonates have been recruited and successfully enrolled and been followed according to the protocol. The preterm neonate with respiratory distress of downe’s score more than or equal to 3 within 6 hours of life is enrolled after stratified block randomization to NIPPV or NCPAP. The demopgraphic data and the downe’s score and the initial settings of ventilation are recorded every 4th hourly. The need for mechanical ventilation is monitored for first 48hrs of Non Invasive Ventilation(NIV) and the outcome is recorded. The total duration of NIV support is also recorded and evaluated. The abdominal girth and rate of feeding is also recorded 4th hourly and daily respectively. ROP evaluation and NSG is being done for each neonate as per NICU protocol. 
Similarly the preterm neonates requiring mechanical ventilation initially and extubated to NIV are also monitored after enrolling and randomization to study.
 
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