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CTRI Number  CTRI/2025/10/096280 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [early versus routine administration of drug]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Early versus Routine Caffeine Use in Premature Infants: a study to improve breathing outcomes 
Scientific Title of Study   Early versus Routine Caffeine Administration in Very Preterm Neonates- a Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
2025-SS-01-005  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nishant Banait 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Neonatology, AIIMS Nagpur, Plot no 2, Sector 20, MIHAN, Nagpur, Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  9673998494  
Fax    
Email  nishantbanait@aiimsnagpur.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anuja Bedekar 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Neonatology, AIIMS Nagpur, Plot no 2, Sector 20, MIHAN, Nagpur, Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  7387106550  
Fax    
Email  dranujabedekar@aiimsnagpur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Anuja Bedekar 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Neonatology, AIIMS Nagpur, Plot no 2, Sector 20, MIHAN, Nagpur, Maharashtra


MAHARASHTRA
441108
India 
Phone  7387106550  
Fax    
Email  dranujabedekar@aiimsnagpur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Nagpur 
 
Primary Sponsor  
Name  Dr Nishant Banait 
Address  Department of Neonatology, AIIMS Nagpur, Plot no 2, Sector 20, MIHAN, Nagpur, Maharashtra 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Anuja Bedekar  Department of Neonatology, AIIMS Nagpur, Plot no 2, Sector 20, MIHAN, Nagpur, Maharashtra 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anuja Bedekar  AIIMS Nagpur  IPD NICU 303, Department of Neonatology, AIIMS Nagpur, Plot no 2, Sector 20, MIHAN, Nagpur, Maharashtra 441108
Nagpur
MAHARASHTRA 
7387106550

dranujabedekar@aiimsnagpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Nagpur Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Early Caffeine   Administration of Caffeine within one hour after birth 
Comparator Agent  Routine caffeine  Administration of caffeine within one to three hours after birth  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  84.00 Day(s)
Gender  Both 
Details  Preterm neonates born at less than 32 weeks gestational age admitted to NICU at AIIMS Nagpur within 3 hours after birth 
 
ExclusionCriteria 
Details  1. Parents and guardians unwilling to provide consent for the study
2. Major Congenital malformations
3. Severe perinatal asphyxia (Apgar score less than 3 at 10 minutes, requiring positive pressure ventilation for more than 10 minutes, requiring chest compressions) 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of bronchopulmonary dysplasia   Requirement of supplemental oxygen at 36 completed weeks of gestational age 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of invasive ventilation  Requirement of invasive ventilation for more Tham initial 12 hours  
Total number of days on mechanical ventilation  till discharge 
Total number of days on oxygen support  till discharge 
Total duration of NICU stay  till discharge 
Postnatal steroid administration  till discharge 
Echocardiographic parameters of systemic blood flow   During initial 48 hours of life 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 2 
Date of First Enrollment (India)   01/11/2025 
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)  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  

With improved survival rates of preterm neonates, there is increase in number of infants with bronchopulmonary dysplasia (BPD). BPD is an important morbidity in very preterm neonates, with global pooled prevalence of 21 percent. Caffeine is a methylxanthine group of drugs. The role of Caffeine for preventing anemia of prematurity, and benefits related to long term neurodevelopmental outcomes are well-known. However, optimal timing of Caffeine initiation remains under investigation. By this study, we aim to fill this gap, and establish the benefits of early administration of Caffeine on respiratory outcomes in very preterm neonates. 

This study aims to compare early versus routine Caffeine administration in very preterm neonates (born at less than 32 weeks gestational age), and its effects on incidence of BPD. 

A prospective, randomized trial will be conducted at the department of Neonatology, AIIMS Nagpur, where eligible neonates will be randomized into intervention and control groups using block randomization. The intervention group will receive standard loading dose of Caffeine (20mg per kg) in the delivery room, within one hour of birth. The control group will receive the same loading dose after NICU admission (within 1 to 3 hours after birth). Respiratory parameters will be monitored. 

Babies will be monitored until 36 completed weeks of corrected gestational age or till hospital discharge, whichever is later. 

The primary objective is to compare the incidence of BPD in very and extremely preterm neonates receiving early versus routine Caffeine administration. Secondary objectives include short term respiratory outcomes, oxygen requirement, requirement of postnatal steroid administration, duration of NICU stay, and echocardiographic parameters of systemic blood flow. 

 
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