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CTRI Number  CTRI/2024/10/074667 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 02/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare higher dose of a drug called caffeine citrate for managing a condition occuring in newborn babies called apnea of prematurity which invloves improving breathing control.  
Scientific Title of Study   A randomized control study comparing two doses of caffeine for apnea of prematurity in tertiary care center. 
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 Gopi Naath  
Designation  Post Graduate Resident 
Affiliation  R.N.T Medical college 
Address  Department of Pediatrics,R.N.T Medical college,Near court chouraha,Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7904939739  
Fax    
Email  gopinaath1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Asif 
Designation  Professor and unit Head 
Affiliation  R.N.T Medical college 
Address  Department of Pediatrics,R.N.T Medical college,Near court choraha, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9785056044  
Fax    
Email  rntianasif@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohammad Asif 
Designation  Professor and unit Head 
Affiliation  R.N.T Medical college 
Address  Department of Pediatrics,R.N.T Medical college,Near court choraha, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9785056044  
Fax    
Email  rntianasif@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  R.N.T Medical college  
Address  R.N.T Medical college and MBGH hospital, Near court Choraha Udaipur 313001 Rajasthan 
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 Gopi Naath  R.N.T Medical college  14, NICU 3RD FLOOR ,inborn, Bal chikitsalaya
Udaipur
RAJASTHAN 		 07904939739

gopinaath1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
R.N.T Medical college and controller and attached hospitals, udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P284||Other apnea of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High Dose Caffeine citrate  Loading dose of 40mg/kg followed by 20mg/kg /day of caffeine citrate for apnea of prematurity till the neonate remains apnea free for 7 days 
Comparator Agent  Standard dose caffeine citrate  Loading dose of 20mg/kg followed by 5-10mg/kg/day of caffeine citrate for apnea of prematurity till the neonate stays apnea free for 7 days 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All new-borns intramuraly delivered with 30 to 34 week GA admitted in Neonatal intensive care, Department of Paediatrics, R.N.T. Medical College, Udaipur, Rajasthan. 
 
ExclusionCriteria 
Details  Severe respiratory distress syndrome,Neonates requiring mechanical ventilation ,Sepsis (culture proven),Neonates with congenital malformation,
Maternal drug use (MgSO4, morphine),Severe intra-ventricular haemorrhage,Newborns requiring Resuscitation,Parents refusing for consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare frequency of apnea and the duration of days with apneic episodes in a higher and standard dose of Caffeine for Apnea in Prematurity  daily and to stop once the neonate remains apnea free for 7 days. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare duration of non-invasive ventilation & duration of oxygen therapy (nasal prong oxygen),time to reach full enteral feeds & adverse effects of caffeine citrate
duration of hospital stay
 		 during discharge & once the neonate becomes stable at room air 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   14/10/2024 
Date of Study Completion (India) 12/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Caffeine is the most commonly used methyl xanthine for the prevention of apnoea in prematurity, but the ideal dose was uncertain, until now. This randomised control study compareS two doses of caffeine for the prevention of apnoea in prematurity. We plan to conduct a clinical trial on 120 preterm infants 30 to 34 weeks in Neonatal Intensive Care Unit. After randomly allocating to receive the intervention (loading 40 mg/kg/day and maintenance of 20 mg/kg/day) or the control (loading 20 mg/kg/ and maintenance of 10 mg/kg/day) dose of caffeine. The primary outcome of the study is to asses frequency and total days of apnea per duration of treatment for both groups. Also other outcomes like duration of respiratory supports and its adverse effects are  also being compared.

 
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