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CTRI Number  CTRI/2024/09/073754 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 31/08/2024
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   Delivery room FiO2 concentration for newborn resuscitation 
Scientific Title of Study   TARGETED OXYGEN (60 PERCENT vs 30 PERCENT) FOR RESUSCITATION IN PRETERM NEONATES BETWEEN 26-32 WEEKS OF GESTATIONAL AGE: A RANDOMIZED CONTROL 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 Sushma Nangia 
Designation  Head of the Department, Neonatology 
Affiliation  Lady Hardinge Medical College 
Address  Lady Hardinge Medical College Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001 New Delhi DELHI 110001 India

New Delhi
DELHI
110001
India 
Phone  9810838181  
Fax    
Email  drsnangia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushma Nangia 
Designation  Head of the Department, Neonatology 
Affiliation  Lady Hardinge Medical College 
Address  Lady Hardinge Medical College Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001 New Delhi DELHI 110001 India

New Delhi
DELHI
110001
India 
Phone  9810838181  
Fax    
Email  drsnangia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prakshi Tyagi 
Designation  DM-Neonatology Resident 
Affiliation  Lady Hardinge Medical College 
Address  Lady Hardinge Medical College Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001 New Delhi DELHI 110001 India

New Delhi
DELHI
110001
India 
Phone  7021265191  
Fax    
Email  prakshityagi973@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College,Shaheed Bhagat SinghMarg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, 110001  
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 
Type of Sponsor  Government medical college 
 
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 Sushma Nangia  Lady Hardinge Medical College  Room no. 335, Department of Neonatology Lady Hardinge Medical College,Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 New Delhi DELHI
New Delhi
DELHI 		 9810838181

drsnangia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P289||Respiratory condition of newborn,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Preterm neonatal Resuscitation at 30% FiO2  Preterm neonate of gestation between 26 and 32 weeks who are initiated at oxygen concentration of 30% for any respiratory support needed during delivery room resuscitation for 20 minutes will be the active control arm.  
Intervention  Preterm neonatal Resuscitation at 60% FiO2  Preterm neonate of gestation between 26 and 32 weeks who are initiated at oxygen concentration of 60% for any respiratory support needed during delivery room resuscitation for 20 minutes will be the intervention arm.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Preterm neonates between 26-32 weeks of gestational age 
 
ExclusionCriteria 
Details  Preterm neonates with gross congenital anomalies 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the initial duration of respiratory support  Daily till discharge or death 
 
Secondary Outcome  
Outcome  TimePoints 
Total duration of respiratory support  Daily till discharge or death 
Common neonatal morbidities [Bronchopulmonary dysplasia stage ≥ 2 (as
per revised NICHD classification)Intraventricular hemorrhage grade (IVH) ≥
grade 2 (as per Volpe’s classification) Retinopathy of prematurity, overall and
those requiring treatment as per RBSK guidelines, Necrotizing enterocolitis] 		 Daily till discharge or death 
All cause mortality  Daily till discharge or death 
Total duration of hospital stay(days)  Daily till discharge or death 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   13/09/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Newborn resuscitation requires anticipation and preparation. It has been proven that term and late preterm newborns have lower short-term mortality when respiratory support during resuscitation is started with 21% oxygen (air) versus 100% oxygen. This has been attributed to lower oxygen toxicity and free radical damage. However, the same principle is difficult to apply on a preterm neonate, especially on very low birth weight neonates. This is because preterm neonates may need supplemental oxygen because of lung immaturity, but antioxidant defenses are also suboptimal until the third trimester. Moreover hypoxia and hyperoxia both can trigger lung injury in very preterm babies, thus prolonging the respiratory support and duration of stay. Very preterm infants often need oxygen supplementation to prevent hypoxia. Extremely preterm infants (i.e., those born below 28 +6 weeks gestation), despite advances in perinatal care, continue to be vulnerable to the consequences of both hypoxia and oxidative stress. Therefore, whereas, resuscitation with 21% has the potential to increase mortality, at the same time 100% oxygen during initial few minutes of life also has the potential to increase the morbidity due to free radical injury. A clinical equipoise hence exists for optimal oxygen use in resuscitation of preterm neonates. This study is hence planned to see the outcome of two oxygen concentrations in intermediate zone (30% and 60%) for delivery room resuscitation in preterm neonates less than 32 weeks of gestation.

  
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