| CTRI Number |
CTRI/2025/11/097459 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Using aluminum foil to improve phototherapy in newborns with jaundice and its effect on their body temperature. |
|
Scientific Title of Study
|
Effectiveness of aluminum foil-assisted phototherapy on bilirubin levels and body temperature among neonates in the selected Tertiary care hospital Mangalore |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankitha V |
| Designation |
Post graduate |
| Affiliation |
Yenepoya nursing college |
| Address |
Department of Child Health Nursing,
Yenepoya Nursing College,
Yenepoya (Deemed to be University),
University Road, Deralakatte,
Mangaluru – 575018, Karnataka, India.
Department of Child Health Nursing,
Yenepoya Nursing College,
Yenepoya (Deemed to be University),
University Road, Deralakatte,
Mangaluru – 575018, Karnataka, India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7204762636 |
| Fax |
|
| Email |
35545@yenepoya.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Benazeera |
| Designation |
Associate Professor Stage-I |
| Affiliation |
Department of Child Health Nursing, Yenepoya Nursing College, Yenepoya (Deemed to be University), University Road, Deralakatte, Mangaluru – 575018, Karnataka, India. |
| Address |
Department of Child Health Nursing,
Yenepoya Nursing College,
Yenepoya (Deemed to be University),
University Road, Deralakatte,
Mangaluru – 575018, Karnataka, India.
Department of Child Health Nursing,
Yenepoya Nursing College,
Yenepoya (Deemed to be University),
University Road, Deralakatte,
Mangaluru – 575018, Karnataka, India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844910806 |
| Fax |
|
| Email |
benazeera@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ankitha V |
| Designation |
Post graduate |
| Affiliation |
Yenepoya nursing college |
| Address |
Department of Child Health Nursing,
Yenepoya Nursing College,
Yenepoya (Deemed to be University),
University Road, Deralakatte,
Mangaluru – 575018, Karnataka, India.
Department of Child Health Nursing,
Yenepoya Nursing College,
Yenepoya (Deemed to be University),
University Road, Deralakatte,
Mangaluru – 575018, Karnataka, India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7204762636 |
| Fax |
|
| Email |
35545@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Nursing College, Yenepoya (Deemed to be University), Deralakatte, Mangalore, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Ankitha V |
| Address |
Yenepoya nursing college
University Road, Deralakatte, Mangaluru, Karnataka 575018 |
| 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 |
| Amkitha V |
Yenepoya Medical College Hospital |
NICU (observational Area)
Division of Pediatric/Neonatal Uint,
University Road, Deralakatte,
Mangaluru – 575018, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA |
7204762634
ankithayen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee - 3 |
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 |
Aluminum foil assisted phototherapy |
Aluminum foil reflectors will be placed around the phototherapy unit to enhance light intensity and coverage area during double surface phototherapy. The procedure will be performed under standard phototherapy guidelines. The distance between the light source and the neonate will be maintained as per protocol. Body temperature and bilirubin levels will be monitored at regular intervals. |
| Comparator Agent |
Standard phototherapy |
Neonates will receive routine double surface phototherapy as per hospital protocol without aluminum foil reflectors. The same monitoring and assessment procedures will be followed for body temperature and bilirubin estimation. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Term nenoates who had
1.Pathological jaundice
2.the bilirubin level greater than or equal to twelve milligrams per deciliter
3.full-term neonates diagnosed within the first seven days of life
4.recommended double surface phototherapy for first time
|
|
| ExclusionCriteria |
| Details |
Term neonates who had
1.hyperbilirubinemia with major congenital anomalies, hemodynamically unstable neonates and neonates on ventilator.
2.recommended to undergo exchanges transfusion
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in total serum bilirubin levels among term neonates receiving aluminum foil-assisted phototherapy compared to standard phototherapy. |
At baseline (before initiation of phototherapy), at 24 hours, and at 48 hours after initiation of phototherapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in body temperature of neonates during phototherapy sessions. |
At baseline and at six hourly intervals during phototherapy. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/11/2025 |
| 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="6"
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 study aims to evaluate the
effectiveness of aluminum foil-assisted phototherapy in reducing serum
bilirubin levels and hyperthermia in neonates with jaundice admitted to the
Neonatal Intensive Care Unit (NICU) at a selected tertiary hospital affiliated
with a university in Mangalore, India. A quasi-experimental study design will
be employed. Neonates requiring phototherapy will be assigned to the control
and experimental groups. Purposive sampling will select neonates meeting the
inclusion criteria (e.g., diagnosed with neonatal jaundice requiring
phototherapy). Exclusion criteria will include contraindications to
phototherapy (e.g., severe hemolytic disease, suspected sepsis). In the
intervention group, phototherapy will be administered with strategically placed
aluminum foil-covered, bow-shaped acrylic sheets molded and positioned above
the infant’s cradle to enhance heat retention and potentially improve
therapeutic efficacy. The control group will receive standard phototherapy.
This study has the potential to provide valuable evidence on the effectiveness
and safety of aluminum foil-assisted phototherapy in managing neonatal
jaundice. Findings from this study may inform clinical practice guidelines and
improve the care of neonates with jaundice. |