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CTRI Number  CTRI/2023/09/057921 [Registered on: 21/09/2023] Trial Registered Prospectively
Last Modified On: 19/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Interrupted Light Therapy in Deeply Jaundiced Neonates 
Scientific Title of Study   Efficacy of Intermittent Phototherapy in Pathological Unconjugated Hyperbilirubinemic Neonates of More Than or equal to 35 Weeks of Gestation – a Randomized Control 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  Dr Ajay Kumar  
Designation  Director Professor 
Affiliation  Maulana Azad Medical College Delhi 
Address  Department of Neonatology Bahadur Shah Zafar Marg

New Delhi
DELHI
110002
India 
Phone  9968604310  
Fax    
Email  AJAYNEONATOLOGY@GMAIL.COM  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Kumar  
Designation  Director Professor 
Affiliation  Maulana Azad Medical College Delhi 
Address  Department of Neonatology Bahadur Shah Zafar Marg

New Delhi
DELHI
110002
India 
Phone  9968604310  
Fax    
Email  AJAYNEONATOLOGY@GMAIL.COM  
 
Details of Contact Person
Public Query  
Name  Dr Susrita Banerjee 
Designation  PG Student 
Affiliation  Maulana Azad Medical College Delhi 
Address  Department of Neonatology Bahadur Shah Zafar Marg

New Delhi
DELHI
110002
India 
Phone  7003715834  
Fax    
Email  susritabanerjee1@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Bahadur Shah Zafar Marg, New Delhi 110002  
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 Ajay Kumar  Maulana Azad Medical College  Department of Neonatology, Lok Nayak Hospital, Jawaher Lal Nehru Marg
New Delhi
DELHI 		 9968604310

AJAYNEONATOLOGY@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P598||Neonatal jaundice from other specified causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Continuous Phototherapy  Single Surface Continuous LED Phototherapy 
Intervention  Intermittent Phototherapy  Single Surface intermittent (six hours on and six hours off sequentially) Light Emitting Diode Phototherapy 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  14.00 Day(s)
Gender  Both 
Details  1.Gestational age more than or equal to 35 weeks, if not ascertainable admission weight >2.4 kg.
2.Clinical jaundice appearing after 24 h of life.
3.Babies with total serum bilirubin (TSB) in the phototherapy range as per
clinical Practice Guidelines AAP 2022
4. TSB<2mg/dl below the threshold for exchange transfusion.
5.Rate of rise of TSB after 6 hours of initial phototherapy less than or equal to
0.2mg/dl/h
 
 
ExclusionCriteria 
Details  1.Major congenital malformations
2.Babies having neurotoxicity risk factors before enrollment(CPG AAP 2022)
a) Serum albumin <3gm/dL
b)Isoimmune hemolytic disease
c)Sepsis(sepsis requiring treatment with antibiotic)
d)Clinical instability in previous 24 hours(cardiopulmonary instability,hypotension requiring pressure support, blood PH <7.15,any respiratory support,sepsis)
3.Direct bilirubin more than 15% or more than 1.5mg/dL of TSB.
4.Baby received PT for more than 5 h before admission.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of fall of TSB measured as mg/dL/h and mg/dL/h/mg of TSB after initial 24 hours of PT  0-28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of rise of TSB measured as mg/dL/h and mg/dL/h/mg of TSB during entire duration of PT  0-28 days 
Rate of rise of TSB more than or equal to 0.2mg/dl/hr  0-28 days 
Rebound of TSB at 12 h of discontinuation of phototherapy  0-28 days 
Baby requiring escalation of care during phototherapy  0-28 days 
Baby requiring Exchange transfusion  0-28 days 
Baby developing BIND(bilirubin induced neurological dysfunction)  0-28 days 
Change in serum Electrolytes (sodium,potassium,calcium)  0-28 days 
Change in Platelet count  0-28 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   27/09/2023 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [AJAYNEONATOLOGY@GMAIL.COM].

  6. For how long will this data be available start date provided 20-09-2023 and end date provided 19-09-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Phototherapy is the most frequently used non-invasive modality of treatment for neonatal hyperbilirubinemia, acts by creating pathways for excretion without conjugation of bilirubin. Because of high quantum yield ,the isomerised form (4z,15E) is rapidly accumulated and at commonly used irradiances, PSS (photostationary state) can be reached in the blood of infants within a few hours of phototherapy. Once PSS reached,absorbed light just shuttles the configuaration back and forth and is wasted with regard to phototherapy. So,intermittent phototherapy is equally efficacious to continuous one.Limited data is available globally and India about the efficacy of intermittent phototherapy in pathological unconjugated hyperbilirubinemia in late preterm and term neonates.Present study attempts to evaluate whether intermittent phototherapy is as effective as continuous phototherapy with least side effects. 
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