FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064781 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Early versus Conventional discontinuation of Caffeine therapy for premature babies with apnea 
Scientific Title of Study   Early versus Conventional discontinuation of Caffeine therapy for Apnea of Prematurity- A Randomized Controlled 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  Nirupa Chandorkar 
Designation  DM Neonatology Resident 
Affiliation  National Institute of Medical Science and Research, Jaipur, Rajasthan 
Address  1st floor, Department of Neonatology Near Neonatal Intensive Care Unit, NIMS Hospital, Jaipur

Jaipur
RAJASTHAN
303121
India 
Phone  7607817322  
Fax    
Email  nirupa005@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gunjana Kumar 
Designation  Assistant Professor 
Affiliation  National Institute of Medical Science and Research, Jaipur, Rajasthan 
Address  1st floor, Department of Neonatology Near Neonatal Intensive Care Unit NIMS Hospital, Jaipur

Jaipur
RAJASTHAN
303121
India 
Phone  7073077130  
Fax    
Email  gunjanakumar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gunjana Kumar 
Designation  Assistant Professor 
Affiliation  National Institute of Medical Science and Research, Jaipur, Rajasthan 
Address  1st floor, Department of Neonatology Near Neonatal Intensive Care Unit NIMS Hospital, Jaipur

Jaipur
RAJASTHAN
303121
India 
Phone  7073077130  
Fax    
Email  gunjanakumar@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Medical Science and Research, Jaipur, Rajasthan 
 
Primary Sponsor  
Name  National Institute of Medical Science and Research Jaipur Rajasthan 
Address  1st floor, Department of Neonatology Near Neonatal Intensive Care Unit NIMS Hospital, Jaipur, Rajasthan 
Type of Sponsor  Private 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 Nirupa Chandorkar  National Institute of Medical Science and Research, Jaipur, Rajasthan  1st floor, Department of Neonatology Near Neonatal Intensive Care Unit NIMS Hospital, Jaipur, Rajasthan
Jaipur
RAJASTHAN 
7607817322

nirupa005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NIMS University Rajasthan, Jaipur  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 
Comparator Agent  Conventional  Caffeine therapy in all preterm neonates for apnea of prematurity will be stopped after they are apnea free and off respiratory support for 5 days and has attained the Post-Menstrual Age (PMA) of 34 weeks 
Intervention  Early  Caffeine therapy in all preterm neonates for apnea of prematurity will be stopped after they are apnea free and off respiratory support for 5 days and has attained the Post-Menstrual Age (PMA) of 33 weeks 
 
Inclusion Criteria  
Age From  7.00 Day(s)
Age To  49.00 Day(s)
Gender  Both 
Details  All preterm infants (both inborn and outborn) with gestational age 26 to 32 weeks and on caffeine therapy for apnea of prematurity fulfilling all the criteria below
a)Neonate with birth weight ≤1250gm or ≤ 30 weeks gestational age or Neonate with 30-32weeks gestational age and on Respiratory support receiving caffeine
b)Babies whose parents have given informed consent
 
 
ExclusionCriteria 
Details  Any one of the following
a)Expired before eligibility
b)Those with major congenital anomalies (antenatally diagnosed or visible at birth)
c)Grade III or IV intraventricular haemorrhage
d)Newborn who has not been weaned off respiratory support till 32+2weeks of Post Menstrual Age (PMA)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The proportion of neonates with the recurrence of apnea after stopping caffeine therapy in both groups will be compared  Death or discharge 
 
Secondary Outcome  
Outcome  TimePoints 
The following clinical outcomes will be compared in both the groups after stoppage of caffeine therapy:
1. Median day of occurrence of apnea after stopping caffeine
2. Post menstrual age at the last dose of caffeine
3. Duration of caffeine therapy
4. Proportion of neonates with feed intolerance
5. Time to regain birth weight
6. Proportion of neonates requiring re-initiation of respiratory support
7. Proportion of neonates with neonatal morbidities including BPD, NEC, PDA and ROP
8. All cause mortality
9. Duration of hospital stay
10. Adverse effect requiring reduction of caffeine dose  
Death or discharge 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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   N/A 
Date of First Enrollment (India)   04/04/2024 
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="0"
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  

Apnea of prematurity (AOP) is a common developmental comorbidity of preterm neonates with its incidence increasing with decreasing gestation. Apnea is defined as cessation of breathing for 20 seconds or longer or a shorter pause accompanied by bradycardia (<100 beats per minute), cyanosis, or pallor. On the basis of respiratory effort and airflow, apnea may be classified as central (cessation of breathing effort), obstructive (airflow obstruction usually at the pharyngeal level), or mixed. The majority of apneic episodes in preterm infants are mixed events, in which obstructed airflow results in a central apneic pause, or vice versa. The commonly used interventions to decrease the frequency and duration of apnea  are continuous positive airway pressure and methylxanthine therapy. 

The indications for starting caffeine in preterm neonates include treatment of apnea, prophylaxis for apnea and peri-extubation. The use of caffeine is associated with certain adverse effects such as tachycardia, emesis, jitteriness, increased oxygen consumption, energy expenditure and reduced weight gainAlthough there is substantial evidence for initiation of caffeine therapy, there is no standard protocol for discontinuation of caffeine therapy and studies are sparse to address this issue. As a general recommendation, most of the neonatal unit continue caffeine till 33 to 34 weeks of gestation when the risk of apnea is low, whereas others stop early, as soon as infants attain a 7-day apnea-free period. The indication and evidence for starting caffeine therapy in preterm neonates is well defined in the literature, however, the time for cessation of caffeine therapy has been consensus-based on the clinician’s decision.

We planned a study to compare the occurrence of apnea in neonates where caffeine will be stopped once the neonate is apnea free and off respiratory support for 5 days and attains the post-menstrual age (PMA) of 33 weeks, with neonates where caffeine will be stopped at 34 weeks of gestation. 


 
Close