| CTRI Number |
CTRI/2018/02/011740 [Registered on: 07/02/2018] Trial Registered Prospectively |
| Last Modified On: |
07/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of stopping phototherapy administered for newborn babies affected by jaundice at low and high serum bilirubin levels. |
|
Scientific Title of Study
|
A comparison of two targets of serum bilirubin concentration for phototherapy discontinuation in neonatal jaundice. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veda Senthil Velan Ganesan |
| Designation |
Postgraduate |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Department of Paediatrics,
PSG Institute of Medical Sciences and Research, Peelamedu,
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
8939462670 |
| Fax |
|
| Email |
doctorvsv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh S |
| Designation |
Associate professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Department of Paediatrics,
PSG Institute of Medical Sciences and Research,
Peelamedu,
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9962823975 |
| Fax |
|
| Email |
drsramesh95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh S |
| Designation |
Associate professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Department of Paediatrics,
PSG Institute of Medical Sciences and Research,
Peelamedu,
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9962823975 |
| Fax |
|
| Email |
drsramesh95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Veda Senthil Velan Ganesan,
Postgraduate, Department of Paediatrics, PSG Institute of Medical Sciences and Research, Peelamedu, Coimbatore. 641004 |
|
|
Primary Sponsor
|
| Name |
Veda Senthil Velan Ganesan |
| Address |
Postgraduate
Department of Paediatrics,
PSG Institute of Medical Sciences and Research,
Peelamedu,
Coimbatore |
| Type of Sponsor |
Other [Principal investigator] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ramesh S |
Associate Professor,
Department of Paediatrics,
PSG Institute of Medical Sciences and Research, Peelamedu,
Coimbatore. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Veda Senthil Velan Ganesan |
PSG Institute of Medical Sciences and Research |
Neonatal Unit, Department of Paediatrics.
Coimbatore
TAMIL NADU |
8939462670
doctorvsv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neonatal jaundice, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Phototherapy will be stopped once serum bilirubin falls 1.0 to 2.9mg/dl below treatment threshold. |
| Comparator Agent |
Group B |
Phototherapy will be stopped once serum bilirubin falls 3.0 mg/dl below treatment threshold |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
1)Babies with gestational age ≥35 weeks,
2)Babies with birth weight >1800 grams,
3)Babies requiring phototherapy for the first time,
4)Babies with onset of jaundice ≤7 days. |
|
| ExclusionCriteria |
| Details |
Babies planned for immediate exchange transfusion at the time of admission |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of babies who require re-initiation of phototherapy. |
24 hours after stopping phototherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total duration of phototherapy including treatment after rebound hyperbilirubinemia and total duration of hospital stay. |
Less than 7 days |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
12/02/2018 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open labelled, parallel group, single centre study comparing the occurance of significant rebound jaundice when phototherapy was stopped in two targets below the treatment threshold in babies with neonatal jaundice. Secondary outcomes will be compared are total duration of phototherapy and total duration of hospital stay in two groups. |