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CTRI Number  CTRI/2015/03/005631 [Registered on: 13/03/2015] Trial Registered Retrospectively
Last Modified On: 07/03/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of continous positive positive pressure (CPAP) delivering devices in Meconium aspiration syndrome (aspiration of fecal contents in utero) in newborn  
Scientific Title of Study   Randomized Control trial of Continuous positive airway pressure versus Standard care in neonates with moderate meconium aspiration syndrome in reducing the need for invasive ventilation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tejopratap Oleti 
Designation  Consultant Neonatology 
Affiliation  Fernadez Hospital 
Address  Department of Neonatology, Second floor, Fernandez Hospital, Hyderguda, Hyderabad
Hyderguda, Hyderabad
Hyderabad
ANDHRA PRADESH
500029
India 
Phone  9989372490  
Fax    
Email  tejopratap@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejopratap Oleti 
Designation  Consultant Neonatology 
Affiliation  Fernadez Hospital 
Address  Department of Neonatology, Second floor, Fernandez Hospital, Hyderguda, Hyderabad
Hyderguda, Hyderabad

ANDHRA PRADESH
500029
India 
Phone  9989372490  
Fax    
Email  tejopratap@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tejopratap Oleti 
Designation  Consultant Neonatology 
Affiliation  Fernadez Hospital 
Address  Department of Neonatology, Second floor, Fernandez Hospital, Hyderguda, Hyderabad
Hyderguda, Hyderabad

ANDHRA PRADESH
500029
India 
Phone  9989372490  
Fax    
Email  tejopratap@gmail.com  
 
Source of Monetary or Material Support  
Fernandez Hospital, Hyderabad 
 
Primary Sponsor  
Name  Fernandez Hospital 
Address  Opp Old MLA quarters, Hyderguda Hyderabad. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aakash Pandita  Neonatal Intensive Care Unit  Second Floor, Fernandez Hospital, Hyderguda, Hyderabad
Hyderabad
ANDHRA PRADESH 		 7674078450

aakash.pandita@gmail.com 
Dr Baswaraj  Vijay Marie Hospital and Educational society  Khairatabad, Hyderabad
Hyderabad
ANDHRA PRADESH 		 9440120081

baswarajt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committe  Approved 
Institute Ethics Committe, Vijay Marie Hospital and Educational Society  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Neonates with Meconium Aspiration Syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CPAP group  Infants randomized to CPAP group would be started on bubble CPAP (Fischer &Paykel) with appropriate sized Hudson prongs. The starting CPAP pressures would be 5cm of water and flow would be adjusted to achieve the desired pressure at the nasal prongs. FiO2 would be adjusted to maintain the saturations between 94and 98%. CPAP pressure and FiO2 will be adjusted to maintain a SpO2 between 94and 98% with a maximum pressure limit of 7cms and FiO2 of 100%. CPAP will be removed when the SpO2 is ≥ 94% with FiO2 requirement 25 % and when the respiratory distress is passive (RR 60/minute, No or mild retractions and no grunt for a minimum duration of 12 hours). Post extubation oxygen will be given either with hood or with binasal oxygen prongs as appropriate. Those with SpO2 95% will be gradually weaned off from the oxygen. CPAP failure would be defined as SpO290% on CPAP pressure of 6cms and FiO2 100%. All infants with CPAP failure would be ventilated.  
Comparator Agent  Standard group  Infants randomized to standard treatment group would be provided with oxygen with a oxyhood containing two port holds. Oxygen would be provided at 5 to 10 liters per min and FiO2 would be adjusted with a FiO2 monitor ensuring saturations between ≥ 94%. Those infants in whom saturations are below 90% more than 15minutes even with 100% FiO2 would be considered for mechanical ventilation or CPAP or non invasive ventilation and will be at the discretion of treating team. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  All neonates born with MSL, developed respiratory distress with Downe’s score > 4 and having typical chest X-ray appearance with
• Oxygen saturation <90% on room air
• Downe’s score > 4
• Gestation >35 weeks and birth weight >2kgs
• Less than 6 hours of life
 
 
ExclusionCriteria 
Details  Neonates with poor respiratory efforts requiring intubation and ventilation, pulmonary air leak syndromes, shock requiring inotropic support and blood pressure with MAP<35mmHg or Major malformations which can comprise the cardio-respiratory status of neonate
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Need for invasive mechanical ventilation in the first 7 days of life will be the primary outcome.   7 days of life 
 
Secondary Outcome  
Outcome  TimePoints 
Death  till discharge 
Pneumothorax  till the baby on CPAP 
Duration of oxygen  till discharge / death 
Duration of ventilation  till discharge /death 
Duration of hospitalization  Till discharge / death 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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)   30/10/2014 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Meconium aspiration syndrome is one of the commonest cause of morbidity in term neonates. Neonates with moderate MAS will be randomized either into CPAP  or standard group after taking written consent from parents. In CPAP group, enrolled neonate will be kept on continuous positive airway pressure (CPAP) according to protocol while in standard group, neonate will be kept on oxygen by hood/ ventilator depending on the respiratory status. They will be monitored for the clinical outcomes till discharge/death. All the neonates will be managed according to standard protocols for the hemodynamic stability and other problems.

 
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