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CTRI Number  CTRI/2024/06/068787 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [PHOTOTHERAPY]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Alternative (Intermittent) Vs Standard (Continous) Treatment (Phototherapy) Methods For Jaundice in Newborns 
Scientific Title of Study   Intermittent versus Continuous phototherapy for neonatal nonhemolytic hyperbilirubinemia in neonates 28 to 34 weeks of gestational age A non inferiority 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  Ishita Singh 
Designation  DM Neonatology Senior Resident 
Affiliation  Sri Ramachandra Medical College 
Address  Department of Neonatology 3rd Floor Sri Ramachandra Medical College

Chennai
TAMIL NADU
600056
India 
Phone  8376890569  
Fax    
Email  ishitarameshsingh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prakash Amboiram 
Designation  Professor 
Affiliation  Sri Ramachandra Medical College 
Address  Department of Neonatology 3rd Floor Sri Ramachandra Medical College

Chennai
TAMIL NADU
600056
India 
Phone    
Fax    
Email  draprakash1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ishita Singh 
Designation  DM Neonatology Senior Resident 
Affiliation  Sri Ramachandra Medical College 
Address  Department of Neonatology 3rd floor Sri Ramachandra Medical College

Chennai
TAMIL NADU
600056
India 
Phone    
Fax    
Email  ishitarameshsingh@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Medical College, No 1 Ramachandra Nagar, Porur, Chennai, 60016- Tamil Nadu, India 
 
Primary Sponsor  
Name  Sri Ramachandra Medical College Porur 
Address  Sri Ramachandra Medical College, Porur Chennai Tamil Nadu 600056 
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 Ishita Singh  Sri Ramachandra Medica College, Chennai  Neonatal Intensive Care Unit
Chennai
TAMIL NADU 
8376890569

ishitarameshsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research Ethics Commitee (For PG Students Of Medical College)  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Continous phototherapy  To be given for 24 hours continuously. Followed by serum bilirubin assessment  
Intervention  Intermittent Phototherapy  Timed,6hourly interrupted phototherapy for neonatal phototherapy- To be given for 12-24 hours till resolution of jaundice i.e. Serum Bilirubin falls below phototherapy cut off 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Neonates 28- 34 weeks gestation with non-hemolytic jaundice 
 
ExclusionCriteria 
Details  Septic Shock with systemic instability
Major congenital and chromosomal anomalies
Severe IVH
Culture proven Meningitis
Babies on phototherapy for indication other than hyperbilirubinenemia
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The rate of fall of serum bilirubin values during the treatment duration   From the time of starting Phototherapy to 24 hours after 
 
Secondary Outcome  
Outcome  TimePoints 
I. Duration of Phototherapy received to treat non hemolytic hyperbilirubinemia
II. Incidence of “IPT Non responders”
III. KMC duration
IV. Weight loss patterns
V. Feed intolerance
VI. Nurse Satisfaction Score
VII. Newborn Skin Condition Scores
 
I. At end of study
II. At end of study period
III. Daily
IV. Daily
V. Daily
VI. One time during treatment period
VII. One time after receiving cumulative at least 24 hours of phototherapy
 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   24/06/2024 
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 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 - NO
Brief Summary  

Neonatal jaundice occurs in 60% term and 80% preterm infants. Continuous Phototherapy(CPT) reduces kernicterus and improves neurodevelopmental outcomes across all gestations. However alterations in mesenteric, cerebral blood flow, DNA damage, risk of carcinogenesis and higher mortality in ELBW babies have been reported. Intermittent Phototherapy(IPT) is a proven non-inferior alternative to CPT in Term and Late Preterm babies. CTRI Registration will be done and the study will be conducted from April 2023-December 2024. With 80 % power and an alpha error of 5 % that indicated intermittent PT is not inferior to continuous PT in terms of rate of fall of bilirubin, 45 neonates will be enrolled in each group with the help of computer generated randomisation. Infants with gestations 28 – 34 weeks of gestations with nonhemolytic hyperbilirubinemia during NICU stay will be enrolled with infants in IPT group receiving  phototherapy for 6 hour cycles. While infants in CPT group will receive phototherapy for 24 hours. Total serum bilirubin (TSB) will be done every 12- 24 h in both groups until criteria for stopping PT is met. Primary outcomes will be -Rate of fall of bilirubin. Data will be presented as number and percentage, mean and standard deviation or median and interquartile range as appropriate. Relevant tests of significance will be applied. Multiple regression analysis will be used to adjust for confounding. p value of <0.05 will be considered statistically significant Intermittent phototherapy may possibly avoid cerebral, splanchnic hemodynamic fluctuations in VLBW infants with preserved skin integrity. Improved KMC hours, decreased mother infant separation can be gained in infants between 28-34 weeks gestation. Finally, it may help NICU to treat more babies with limited phototherapy units across all gestations.

 
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