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CTRI Number  CTRI/2022/01/039339 [Registered on: 11/01/2022] Trial Registered Prospectively
Last Modified On: 08/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study comparing safety of two drug regimens for dilatation of eyes before retinopathy of prematurity screening in preterm neonates: A double blinded Randomized Controlled Trial  
Scientific Title of Study   Comparing safety of two drug regimens for pupillary dilatation for retinopathy of prematurity screening in preterm neonates: A double blinded 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  Dr Gautam Kumar Vasnik 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of Pediatrics, Division of Neonatology, AIIMS, New Delhi
Department of Pediatrics, Division of Neonatology, AIIMS, New Delhi
New Delhi
DELHI
110029
India 
Phone  9545252361  
Fax    
Email  gautam_vasnik@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Ankit Verma 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  AIIMS, New Delhi
Neonatology Division Dept of Pediatrics AIIMS New Delhi
New Delhi
DELHI
110029
India 
Phone  9868979309  
Fax    
Email  ankitvmmc@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Gitanjali Jain 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of Pediatrics, Division of Neonatology, AIIMS, New Delhi
Department of Pediatrics, Division of Neonatology, AIIMS, New Delhi
New Delhi
DELHI
110029
India 
Phone  9545257617  
Fax    
Email  gitanjali_jain@yahoo.co.in  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 
Gitanjali Jain  AIIMS, New Delhi  Division of Neonatology Department of Pediatrics AIIMS New Delhi, 110029
New Delhi
DELHI 		 09545257617

gitanjali_jain@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, New Delhi Ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Instillation of mydriatic drops for dilatation before retinopathy of prematurity screening  Instillation of a 3-step combination of 0.5% tropicamide plus 0.5% tropicamide followed by 2.5% phenylephrine+0.5% tropicamide 
Comparator Agent  Instillation of mydriatic drops for dilatation before retinopathy of prematurity screening  Instillation of combination of 2.5% Phenylephrine+ 0.5% Tropicamide used thrice 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  5.00 Month(s)
Gender  Both 
Details  Gestational age at birth is less than 34 weeks or birth weight <1500 gm

 
 
ExclusionCriteria 
Details  1. Major malformation
2. Hemodynamic instability
3. Suspicion of cardiovascular disease
4. Anatomical variations of the anterior segment
5. Consent denied by the parents/ attendants 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
a 3-step combination of
0.5% tropicamide plus 0.5% tropicamide followed by 2.5% phenylephrine+0.5%
tropicamide vs. a combination of 2.5% phenylephrine+0.5% tropicamide used
thrice will cause 50% less increase in diastolic
blood pressure  		 15 minutes after the retinopathy of prematurity screening procedure  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the mydriatic efficacy and suitability of pupillary dilatation by assessing the need for rescue dose of the two mydriatic regimens being compared.   Before ROP screening (after instillation of mydriatic drops) to 24 hrs after 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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)   12/01/2022 
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="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [gitanjali_jain@yahoo.co.in].

  6. For how long will this data be available start date provided 12-01-2024 and end date provided 11-01-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No
Brief Summary  

·        Retinopathy of prematurity (ROP) is a common complication related to preterm neonates. Various dilatation protocols are being used for mydriasis during ROP screening. We aim to compare the safety of two mydriatic regimens using 0.5% Tropicamide two times followed by 2.5% Phenylephrine+ 0.5% Tropicamide (intervention group) Vs combination of 2.5% Phenylephrine+ 0.5% Tropicamide used thrice (control group). We hypothesize that using the 3-step combination of 0.5% tropicamide plus 0.5% tropicamide plus 0.5% tropicamide+2.5% phenylephrine eye drops for pupillary dilatation in preterm neonates undergoing ROP screening will result in 50% less increase in the diastolic blood pressure and heart rate at 15+5 minutes after screening, when compared to use of 0.5 % tropicamide+ 2.5% phenylephrine combination eye drops used thrice.

 
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