| 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
|
|
|
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
|
|
|
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
|
|
|
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
|