| 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
|
|
|
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. |