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CTRI Number  CTRI/2023/10/059205 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARISON OF CONTINUOUS AND INTERMITTENT PHOTOTHERAPY IN HEALTHY TERM NEONATES WITH HYPERBILIRUBINEMIA  
Scientific Title of Study   COMPARISON OF EFFECTIVENESS OF CONTINUOUS AND INTERMITTENT PHOTOTHERAPY ON HEALTHY TERM NEONATES WITH HYPERBILIRUBINEMIA - A RANDOMISED CONTROL TRIAL 
Trial Acronym  RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR DURGESH KUMAR 
Designation  ASSOCATE PROFESSOR 
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai, Etawah 
Address  Department of Pediatrics Uttar Pradesh University of Medical Sciences, Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9917144512  
Fax    
Email  drdurgeshk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DURGESH KUMAR 
Designation  ASSOCATE PROFESSOR 
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai, Etawah 
Address  Department of Pediatrics Uttar Pradesh University of Medical Sciences, Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9917144512  
Fax    
Email  drdurgeshk@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR DURGESH KUMAR 
Designation  ASSOCATE PROFESSOR 
Affiliation  Uttar Pradesh University of Medical Sciences, Saifai, Etawah 
Address  Department of Pediatrics Uttar Pradesh University of Medical Sciences, Saifai, Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9917144512  
Fax    
Email  drdurgeshk@gmail.com  
 
Source of Monetary or Material Support  
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, SAIFAI, ETAWAH 
 
Primary Sponsor  
Name  Uttar Pradesh University of Medical Sciences Saifai Etawah 
Address  Uttar Pradesh University of Medical Sciences, Saifai, Etawah 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Durgesh Kumar  Uttar Pradesh University of Medical Sciences, Saifai, Etawah  NICU and SNCU of Department of Pediatrics Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Etawah
UTTAR PRADESH 		 09917144512

drdurgeshk@gmail.com 
Dr R Nivethaashree   Uttar Pradesh University of Medical Sciences, Saifai, Etawah  NICU and SNCU of Department of Pediatrics Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Etawah
UTTAR PRADESH 		 9159307663

niveeshree26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, Uttar Pradesh University of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P599||Neonatal jaundice, unspecified, (2) ICD-10 Condition: P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Continuous phototherapy  3 hours on and 3 hours off cycles of phototherapy 
Intervention  Intermittent Phototherapy   Continuous vs. 3 hours on and 3 hours off phototherapy  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  Babies whose bilirubin level is above the range of pathological hyperbilirubinemia as per American academy of pediatrics nomogram irrespective of cause of hyperbilirubinemia.
Term babies who have weight above 2.5kg.
Babies less than 7days of life.
Both male and female babies are included.
 
 
ExclusionCriteria 
Details  Parents who are not giving consent for the study.
Babies who are having low birth weight and sick babies
All term neonates with unstable vitals.
Neonates admitted after 7th day of birth.
Babies who are having congenital abnormalities.
Babies whose total serum bilirubin falling in the exchange transfusion range at the time of admission, requiring NICU admission for any reason other than jaundice.
Babies with direct bilirubin >20% of total bilirubin or direct bilirubin >2.0mg/dl
Babies who have received prior phototherapy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of fall of bilirubin in term neonates   After stopping the phototherapy  
 
Secondary Outcome  
Outcome  TimePoints 
Hospital stay and rebound hyperbilirubinemia   After stopping the phototherapy  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/11/2023 
Date of Study Completion (India) 31/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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
Modification(s)  		 This study is a randomized, single blind, parallel group, active controlled trial comparing the effectiveness of continuous and intermittent phototherapy (3 hours on and 3 hours off cycles) in term neonates with hyperbilirubinemia. The primary outcome measure will be rate of fall of bilirubin. Secondary outcome will be hospital stay and rebound of hyperbilirubinemia. 
 
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