| CTRI Number |
CTRI/2025/07/090837 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [PHOTOTHERAPY] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Helping Newborns with Jaundice: Comparing the Old and New AAP Treatment Charts |
|
Scientific Title of Study
|
Evaluation of Midazolam, Ketamine, and Dexmedetomidine for Pediatric Premedication Prior to Radiological Imaging: A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
REXINA DARTHY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
| Address |
C BLOCK
DEPARTMENT OF NEONATOLOGY CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
Chennai
TAMIL NADU
603103
India |
| Phone |
9043593599 |
| Fax |
|
| Email |
rexinadarthyjs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GIRIDHAR |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
CHETTINA HOSPITAL AND RESEARCH INSTITUTE |
| Address |
C BLOCK
DEPARTMENT OF NEONATOLOGY
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
Chennai
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GIRIDHAR |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
CHETTINAD HOSPITAL AND RESEARCH CENTRE |
| Address |
C BLOCK
DEPARTMENT OF NEONATOLOGY
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
Chennai
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
|
Source of Monetary or Material Support
|
| C BLOCK
DEPARTMENT OF NEONATOLOGY
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
TAMIL NADU - 603103
INDIA |
|
|
Primary Sponsor
|
| Name |
DR REXINA DARTHY |
| Address |
C BLOCK
DEPARTMENT OF NEONATOLOGY
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
TAMIL NADU - 603103
INDIA |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DR REXINA DARTHY |
HOSPITAL |
C BLOCK
DEPARTMENT OF NEONATOLOGY
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE
TAMIL NADU - 603103
INDIA
Chennai
TAMIL NADU |
9043593599
rexinadarthyjs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHETTINAD ACADEMY OF RESEARCH AND EDUCATION INSTITUTIONAL HUMAN ETHICS COMMITTEE FOR STUDENT RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P599||Neonatal jaundice, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
PHOTOTHERAPY |
BABIES WHOSE BILIRUBIN VALUES THAT IS TAKEN AFTER 48 HOURS OF LIFE ARE ABOVE THE CUT OFF OF OLD CHART FOR GROUP A AND NEW CHART FOR GROUP B ARE STARTED WITH PHOTOTHERAPY |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
Newborn babies more than or equal to 35 weeks of gestation age with neonatal hyperbilirubinemia. |
|
| ExclusionCriteria |
| Details |
Any newborn having major congenital malformations is excluded, Parents denying consent, SGA babies with Birth weight less than 3rd as per Fenton Chart.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Rebound jaundice bilirubin level post-discontinuation of phototherapy that is taken 24hours after stopping phototherapy requiring re-initiation of phototherapy within 4 weeks |
To compare Rebound jaundice bilirubin level post-discontinuation of phototherapy that is taken 24hours after stopping phototherapy requiring re-initiation of phototherapy within in 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To Compare the need for phototherapy
2.Duration of phototherapy
3.Requirement of readmission for phototherapy
4.Need for sampling to measure the bilirubin levels
5.Need for exchange transfusion
|
within 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="550"
Sample Size from India="550"
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)
|
23/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
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
|
Neonatal hyperbilirubinemia is a common problem faced by the pediatricians managing newborns. It is the seventh most common of cause of neonatal mortality in first 7 days of life worldwide and can lead to devastating long term sequelae including kernicterus spectrum disorder. Comparing the bilirubin levels in both New and Old American Academy of Paediatrics standard charts to estimate the need for phototherapy. To know the duration of hospital stay in view of phototherapy. To find the requirements of readmission for phototherapy. This proposal may compare the the rebound jaundice bilirubin level post-discontinuation of phototherapy requiring re-initiation of treatment, need for phototherapy, duration of hospital stay, requirement of readmission for phototherapy between new and old IAP charts. Any newborn having major congenital malformations is excluded and also Parents denying consent. |