| CTRI Number |
CTRI/2024/10/075529 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of intermittent Versus continuous phototherapy for jaundice in neonates more than 35 weeks of gestational age-A randomised controlled trial |
|
Scientific Title of Study
|
Effectiveness of intermittent Versus continuous phototherapy for indirect hyperbilirubinemia in neonates more than 35 weeks of gestational age-A randomised controlled 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 |
Namrata Kumari |
| Designation |
DM neonatology resident |
| Affiliation |
Chengalpattu medical college and hospital |
| Address |
New cemonc
Department of neonatology
Chengalpattu medical college and hospital
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8969253875 |
| Fax |
|
| Email |
namratakrpmch04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S.Manikumar |
| Designation |
Assistant professor |
| Affiliation |
Chengalpattu Medical college and Hospital |
| Address |
New cemonc
Department of neonatology
Chengalpattu medical college and hospital
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9841781037 |
| Fax |
|
| Email |
drneomani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namrata Kumari |
| Designation |
DM neonatology resident |
| Affiliation |
Chengalpattu medical college and hospital |
| Address |
New cemonc
Department of neonatology
Chengalpattu medical college and hospital
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8969253875 |
| Fax |
|
| Email |
namratakrpmch04@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Namrata Kumari |
| Address |
New cemonc
Department of neonatology
Chengalpattu medical college and hospital |
| Type of Sponsor |
Other [DM resident ] |
|
|
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 Namrata Kumari |
Chengalpattu Medical college and Hospital |
2nd floor New cemonc Department of Neonatology Chengalpattu Medical college and Hospital
Kancheepuram
TAMIL NADU |
8969253875
namratakrpmch04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Chengalpattu Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period, (2) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuous phototherapy |
6 months
Continuous phototherapy interrupted only for feeding and cleaning |
| Intervention |
Intermittent Phototherapy |
6 months
3 hours on and 3 hours off |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All neonates with gestational age more than or equal to 35 weeks with non hemolytic hyperbilirubinemia |
|
| ExclusionCriteria |
| Details |
Hemolytic anemia
Babies who are having congenital abnormalities
Prematurity
Birth asphyxia
Assisted delivery
Direct hyperbilirubinemia
Onset of jaundice within first 24 hours of life
Babies who are on ventilator
Parents who are not willing |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measure rate of fall of bilirubin in two groups |
At baseline,at end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare duration of hospital stay among the groups |
Six months |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
03/11/2024 |
| 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="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
|
The study is intended to compare intermittent versus continuous phototherapy in treatment of neonatal non-haemolytic hyperbilirubinemia. Jaundiced babies are randomised in two arms,in Intermittent group ,phototherapy is given for 3 hours on and 3 hours off.In continuous arm,phototherapy is given continuously interrupted only for feeding and cleaning. |