| CTRI Number |
CTRI/2024/09/073562 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Phototherapy with Kangaroo mother care] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of phototherapy with and without Kangaroo mother care in neonatal jaundice |
|
Scientific Title of Study
|
Comparison of effectiveness of phototherapy with and without Kangaroo mother care in preterm neonates with hyperbilirubinemia a randomized control 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 |
Durgesh Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of Pediatrics
Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09917144512 |
| Fax |
|
| Email |
drdurgeshk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mohd. Ziyauddin Ali Ansari |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of Pediatrics
Uttar Pradesh University of Medical Sciences, Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9196169775 |
| Fax |
|
| Email |
ziyauddinansari2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DURGESH KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of Pediatrics
Uttar Pradesh University of Medical Sciences, Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09917144512 |
| Fax |
|
| Email |
drdurgeshk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University Of Medical Sciences, Saifai, Etawah, Uttar Pradesh, India
Postal code- 206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Saifai, Etawah |
| Type of Sponsor |
Government 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 |
| Dr Durgesh Kumar |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
NICU and SNCU of
Department of
Pediatrics Uttar
Pradesh University of
Medical Sciences,
Saifai, Etawah
Etawah
UTTAR PRADESH
Etawah
UTTAR PRADESH |
09917144512
drdurgeshk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Uttar Pradesh University of Medical Sciences |
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 |
Continuous Phototherapy |
Continuous Phototherapy for 24 hours except the time for feeding |
| Intervention |
Phototherapy with Kangaroo mother care |
4 Cycles in a day with each cycle consist of 4 hours of phototherapy and 2 hours of Kangaroo mother care (Total 16 hours phototherapy and 8 hours of Kangaroo mother care) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Pre-term neonates whose bilirubin level is above the range of pathological hyperbilirubinemia as per American academy of pediatrics nomogram irrespective of cause of hyperbilirubinemia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of fall of bilirubin in term neonates |
After 12 hours, 24 hours, 36 hours and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hospital stay & rebound hyperbilirubinemia |
After 24 hours 36 hours & 48 hours |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drdurgeshk@gmail.com].
- For how long will this data be available start date provided 01-09-2025 and end date provided 30-09-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, single blind, parallel group, active controlled trial comparing the effectiveness of continuous phototherapy and phototherapy with Kangaroo mother care (2 hours Kangaroo mother care after each 6 hours of phototherapy) in Pre-term neonates with hyperbilirubinemia. The primary outcome measure will be rate of fall of bilirubin. Secondary outcome will be hospital stay and rebound of hyperbilirubinemia. |