FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063926 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 10/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Different Caffeine Amounts to Prevent Breathing Problems in Premature Babies: A Study (HI-CAF Trial) 
Scientific Title of Study   Higher versus Standard Caffeine dosing in Prevention of Apnoea of Prematurity: A Randomized Controlled Trial (HI-CAF trial)  
Trial Acronym  HI-CAF trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Asha M N 
Designation  Senior Resident 
Affiliation  IMS and SUM Hospital 
Address  Department of Neonatology, IMS and SUM Hospital, K8 Kalinganagar, Shampur Bhubaneswar, Kordha
No 468 Inchara 4th main near PES Degree College, Nagendra Block Bengaluru South, Banashankari, Karnataka 560050
Khordha
ORISSA
751003
India 
Phone  9538205450  
Fax    
Email  drashamn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Debasish Nanda 
Designation  Professor 
Affiliation  IMS and SUM Hospital 
Address  Department of Neonatology, IMS and SUM Hospital, K8 Kalinganagar, Shampur Bhubaneswar Khordha Odisha.

Khordha
ORISSA
751003
India 
Phone  9861422685  
Fax    
Email  debasishnanda@soa.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Asha M N 
Designation  Senior Resident 
Affiliation  IMS and SUM Hospital 
Address  Department of Neonatology, IMS and SUM Hospital, K8 Kalinganagar, Shampur Bhubaneswar Khordha Odisha.
No 468 Inchara 4th main near PES Degree College, Nagendra Block Bengaluru South, Banashankari, Karnataka 560050
Khordha
ORISSA
751003
India 
Phone  9538205450  
Fax    
Email  drashamn@gmail.com  
 
Source of Monetary or Material Support  
IMS and SUM hospital, Bhubaneswar, Odisha 
 
Primary Sponsor  
Name  Dr Asha M N 
Address  Department of Neonatology, IMS and SUM Hospital, K8 Kalinganagar, Shampur Bhubaneswar Khordha Odisha. 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Debasish Nanda  Department of Neonatology, IMS and SUM Hospital, K8 Kalinganagar, Shampur Bhubaneswar Khordha Odisha. 751003 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asha M N  IMS and SUM Hospital  Department of Neonatology, Site name NICU, IMS and SUM Hospital, K8 Kalinganagar, Shampur Bhubaneswar Khordha Odisha.
Khordha
ORISSA 		 9538205450

DRASHAMN@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Medical Sciences (IMS) And SUM Hospital Siksha O Anusandhan (Deemed to be University)  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  higher dose of caffeine  All eligible neonates will be stratified into 2 groups of less than 30 weeks and 30+1 to 31+6 weeks and will be randomised using web based randomisation into 2 arms, intervention and comparision arm, the intervention arm will recieve higher dose caffeine 40mg per kg per dose followed by maintainance of 10-20mg per kg per dose. The treatment will be stopped once baby reaches 33-34 weeks of post menstrual age and not on respiratory support. 
Comparator Agent  standard dose of caffeine  All eligible neonates will be stratified into 2 groups of less than 30 weeks and 30+1 to 31+6 weeks and will be randomised using web based randomisation into 2 arms, intervention and comparision arm, the comparison arm will recieve standard dose caffeine 20mg per kg per dose followed by maintainance of 5-10mg per kg per dose. The treatment will be stopped once baby reaches 33-34 weeks of post menstrual age and not on respiratory support. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All neonates less than 30 weeks of gestation and
Neonates between 30+1 to 31+6 who develop recurrent apnoea.  
 
ExclusionCriteria 
Details  Major Congenital anomaly or Chromosomal abnormalities and
Parents who do not consent
 
 
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 
The proportion of apnoea of prematurity   Upto 28 days of life 
 
Secondary Outcome  
Outcome  TimePoints 
The rates of failure of extubation.   anytime during hospital stay. 
Incidence of PDA, NEC, IVH, PVL, ROP and AKI.
 		 anytime during hospital stay.
 
Duration of respiratory support.  anytime during hospital stay.
 
The time to reach full enteral feeding.   anytime during hospital stay. 
Number of NPO hours  anytime during hospital stay. 
The incidence of Hypertension.
 		 anytime during hospital stay. 
Growth velocities( average weekly weight gain in first month of life and average weight gain during NICU stay)
 		 anytime during hospital stay. 
The incidence of Seizures.
 		 anytime during hospital stay. 
Severe adverse events.
 		 anytime during hospital stay. 
BPD
 		 anytime during hospital stay. 
Mortality
 		 anytime during hospital stay. 
 
Target Sample Size   Total Sample Size="348"
Sample Size from India="348" 
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/ Phase 3 
Date of First Enrollment (India)   22/03/2024 
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="6"
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  

Our study, titled "Higher versus Standard Caffeine dosing in Prevention of Apnoea of Prematurity (HI-CAF trial)," investigates the efficacy of a higher dose of caffeine in reducing Apnea of Prematurity (AoP) compared to standard dosing. With a global rise in premature births, the research addresses the need for optimal management, particularly in low- and middle-income countries. The study design is a randomized controlled trial conducted in an Indian neonatal unit, focusing on neonates below 32 weeks gestation. The primary outcome is the proportion of Apnoea of Prematurity, with secondary outcomes including the rates of  failure of extubation, Incidence of PDA, NEC, IVH, PVL, ROP and AKI, Duration of respiratory support,

The time to reach full enteral feeding, Number of NPO hours, The incidence of Hypertension,

Growth velocities( average weekly weight gain in first month of life and average weight gain during NICU stay), The incidence of Seizures, Severe adverse events, BPD and Mortality. The methodology involves randomization into higher and standard dose caffeine groups, and the study aims to contribute valuable insights to the inconsistent data on caffeine dosing. The study period is for 18 months, and the statistical analysis will employ chi-square tests and t-tests, presenting results with a significance threshold of p < 0.05. The study seeks to address gaps in literature, particularly in the context of limited evidence from low- and middle-income countries, and aims to provide practical implications for neonatal care.


 
Close