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CTRI Number  CTRI/2016/12/007559 [Registered on: 09/12/2016] Trial Registered Retrospectively
Last Modified On: 10/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to evaluate the duration of caffeine therapy for apnea of prematurity  
Scientific Title of Study   Comparison of two durations of caffeine therapy on clinically significant apnea - A randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raj Prakash 
Designation  Senior Resident 
Affiliation  Kerala Institute of Medical Science 
Address  Department of Neonatology, Kerala Institute of Medical Science,Trivandrum

Thiruvananthapuram
KERALA
695029
India 
Phone  9846023482  
Fax    
Email  rajprakash84@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Naveen Jain 
Designation  Senior Consultant 
Affiliation  Kerala Institute of Medical Science 
Address  Department of Neonatology, Kerala Institute of Medical Science,Trivandrum

Thiruvananthapuram
KERALA
695029
India 
Phone  9387814568  
Fax    
Email  naveen_19572@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Raj Prakash 
Designation  Senior Resident 
Affiliation  Kerala Institute of Medical Science 
Address  Department of Neonatology, Kerala Institute of Medical Science,Trivandrum

Thiruvananthapuram
KERALA
695029
India 
Phone  9846023482  
Fax    
Email  rajprakash84@gmail.com  
 
Source of Monetary or Material Support  
Kerala Institute of Medical Science, P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India 
 
Primary Sponsor  
Name  Kerala Institute of Medical Science 
Address  Kerala Institute of Medical Science, P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Dr Naveen Jain  Senior Consultant, Department of Neonatology, Kerala Institute of Medical Science,P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raj Prakash  Kerala Institute of Medical Science  Department of Neonatology, Kerala Institute of Medical Science,P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India
Thiruvananthapuram
KERALA 		 9846023482

rajprakash84@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Apnea of Prematurity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Longer duration of Caffeine therapy- Continuing caffeine for Apnea of Prematurity till infants reach 34 completed weeks.  caffeine therapy in all premature infants for treatment of apnea will be continued till infants reach 34 completed weeks. 
Intervention  Short duration caffeine therapy-Stopping Caffeine for Apnea of Prematurity after 7 apnea free days.  Caffeine therapy in all premature infants for treatment of apnea will be stopped after attaining 7 apnea free days. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All babies with birth gestation between 26 – 32 weeks, on caffeine therapy.
Indications for caffeine therapy:
1)As treatment for apnea of prematurity.
2)Prophylactic caffeine therapy in extremely low birth weight infants (birth weight below 1000 g) to avoid intubation and mechanical ventilation, or to enhance extubation.
3)Periextubation caffeine for infants less than 32 weeks and those intubated for RDS.
 
 
ExclusionCriteria 
Details  ●Major congenital anomalies
●Grade 111 or 1V Intraventricular Hemorrhage (IVH).
●On drugs that can cause central nervous system depression – morphine, midazolam, antiepileptic drugs (AED)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of babies having clinically significant apnea from randomization till transfer to room in each of the two groups.  till rooming in. 
 
Secondary Outcome  
Outcome  TimePoints 
Gestation specific day of recurrence of apnea from the day caffeine is stopped.
 		 till rooming in. 
Recurrence risk of apnea in subgroup of babies with minimal vs moderate to severe respiratory illness after birth  till rooming in. 
Proportion of babies requiring interventions for apnea of prematurity , after excluding those with apnea secondary to new sepsis, primary pulmonary pathology (pneumthorax, collapse, pulmonary hemorrhage, pneumonia), anemia, hyponatremia, preterm brain injury (USG cranium / MRI – PVL stage 2 or more), GERD requiring therapy, upper airway problems requiring intervention, inborn errors of metabolism  till rooming in 
EUGR (extrauterine growth retardation, Z from birth weight) on gender specific Fentons chart   at discharge 
NEC/feed intolerance / tachycardia requiring decrease in caffeine dose  till rooming in 
Oxygen dependency at postnatal day 28  28 days postnatal age  
Neurological Outcome at discharge assessed by Hammersmith examination  at discharge 
ROP requiring laser treatment
 		 till requiring treatment 
Abnormal USG cranium at 36-40 weeks
 		 36-40 weeks 
All cause mortality during initial hospitalization  during hospital stay 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
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)   05/08/2015 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

This is a Prospective,Randomized Controlled Trial to compare the differences in proportion of infants having clinically significant apnea when caffeine therapy is discontinued after the preterm infant has attained 7 apnea free days ( group 1 ) vs continuing caffeine till 34 weeks postmenstrual age ( group 2). The study is being conducted in  a level IIIB 25 bedded referral Neonatal Intensive Care Unit for a period of 2 years (Augest 2015 to July 2017).174 preterm infants on caffeine therapy with birth gestation between 26-32 weeks is included in the study. The primary outcome is proportion of babies having clinically significant apnea from randomization till transfer to room in each of group 1 and group 2.


 
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