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CTRI Number  CTRI/2026/01/101515 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   EFFICACY OF ALUMINIUM FOIL REFLECTOR FOR PHOTOTHERAPY IN NEONATAL JAUNDICE TO REDUCE THE DURATION OF PHOTOTHERAPY COMPARITIVE STUDY BETWEEN CONVENTIONAL PHOTOTHERAPY  
Scientific Title of Study   EFFECT OF ALUMINUM FOIL REFLECTOR-ENHANCED PHOTOTHERAPY IN NEONATAL JAUNDICE:A RANDOMIZED CONTROLLED TRAIL 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAVIKUMARS 
Designation  MBBS MD PAEDIATRICS 
Affiliation  VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL 
Address  VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL DEPARTMENT OF PAEDIATRICS KEEZHAKASAKUDY MEDU PUDUCHERRY PIN 609609
DEPARTMENT OF PAEDIATRICS
Karaikal
PONDICHERRY
609609
India 
Phone  7708077996  
Fax    
Email  mdsrk93@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  RAVIKUMARS 
Designation  MBBS MD PAEDIATRICS 
Affiliation  VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL 
Address  VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL DEPARTMENT OF PAEDIATRICS KEEZHAKASAKUDY MEDU PUDUCHERRY PIN 609609
DEPARTMENT OF PAEDIATRICS
Karaikal
PONDICHERRY
609609
India 
Phone  7708077996  
Fax    
Email  mdsrk93@gmail.com   
 
Details of Contact Person
Public Query
 
Name  RAVIKUMARS 
Designation  MBBS MD PAEDIATRICS 
Affiliation  VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL 
Address  VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL DEPARTMENT OF PAEDIATRICS KEEZHAKASAKUDY MEDU PUDUCHERRY PIN 609609
DEPARTMENT OF PAEDIATRICS
Karaikal
PONDICHERRY
609609
India 
Phone  7708077996  
Fax    
Email  mdsrk93@gmail.com   
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  vinayaka missions medical college 
Address  vinayaka missions medical college and hospital karaikal 609609 
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 
Bhavitha  vinayaka missions medical college  DEPARTMENT OF PAEDIATRICS vinayaka mission medical college karaikal pondicherry 609609
Karaikal
PONDICHERRY 
8247421397

bhavithagiraboina@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  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  aluminium foil phototherapy  use of aluminium foil as an adjuvent will reduce the duration of need of phototherapy 
Comparator Agent  conventional phototherapy  this is standard phototherapy which we normally use 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  14.00 Day(s)
Gender  Both 
Details  CLINICAL JAUNDICE 
 
ExclusionCriteria 
Details  MAJOR CONGENITAL ANAMOLIES
ON VENTILATOR
BILIRUBIN LEVELS NEAR EXCHANGE TRANSFUSION RANGE
HEMODYNAMIC INSTABILITY
HEMOLYTIC DISEASE
ELEVATED DIRECT BILIRUBIN 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
REDUCE DURATION OF PHOTOTHERAPY
 
24hours 
 
Secondary Outcome  
Outcome  TimePoints 
reduction of hospital stay   24hours 
 
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)   29/01/2026 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This randomized controlled trial evaluated the efficacy and safety of aluminium foil reflectorassisted phototherapy compared with standard LED phototherapy in term neonates with hyperbilirubinemia The findings showed that the use of aluminium foil reflectors produced a greater reduction in serum bilirubin levels after 24 hours a faster rate of bilirubin decline and a shorter total duration of therapy These results indicate that reflective materials around phototherapy units enhance light delivery to the neonate and improve bilirubin photoisomerization and elimination

aluminium foil reflectors were positioned around the phototherapy unit to redirect scattered light back toward the neonate, increasing the effective light intensity Aluminium foil reflects visible light producing a more uniform illumination field without requiring extra energy or light sources This enhanced irradiance likely explains the greater bilirubin reduction and shorter treatment duration observed in the reflector group The reflector setup improved the photochemical conversion of bilirubin to lumirubin and other photoisomers facilitating faster excretion

Existing evidence has shown that reflective surfaces can increase light intensity and improve treatment outcomes during phototherapy The present findings align with this concept and confirm that adding low-cost reflective materials can optimize the efficiency of modern LED based units Enhanced light utilization improves the therapeutic impact without expensive equipment upgrades an advantage for neonatal care units with limited resources or non uniform irradiance across the infants body

The faster bilirubin decline in the reflector group can be attributed to reduced light scattering and better photon absorption on the neonates skin surface Improved reflection allows a greater proportion of light to reach the dermal layer where bilirubin is concentrated thus increasing the rate of photoisomer formation

The studys findings hold important implications for neonatal care in low- and middle-income countries Many healthcare centers rely on older or single surface phototherapy units with limited irradiance In such contexts using simple and inexpensive materials like aluminium foil can markedly enhance treatment outcomes

 

 
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