| CTRI Number |
CTRI/2021/08/035727 [Registered on: 17/08/2021] Trial Registered Prospectively |
| Last Modified On: |
17/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of the phototherapy units in babies with jaundice |
|
Scientific Title of Study
|
Close Range Immersive Phototherapy Vs Standard Phototherapy in babies with hyperbilirubinemia (CRimP) – A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr sushma Krishnegowda |
| Designation |
Assistant Professor |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Department of Pediatrics, NICU, 2nd floor
JSS Hospital
Agrahara, Mysore
Department of Pediatrics,
JSS Medical College,
Bannimantap, Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9742299896 |
| Fax |
|
| Email |
drsushmasri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sushma Krishnegowda |
| Designation |
Assistant Professor |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Department of Pediatrics, 2nd floor, NICU, JSS Hospital,
Agrahara, Mysore
Department of Pediatrics
JSS Medica College, Bannimantap,Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9742299896 |
| Fax |
|
| Email |
drsushmasri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sushma Krishnegowda |
| Designation |
Assistant Professor |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Department of Pediatrics, 2nd floor, NICU,JSS Hospital
Agrahara, Mysore
Department of Pediatrics, JSS Medical College, Bannimantap
Mysore
KARNATAKA
570004
India |
| Phone |
9742299896 |
| Fax |
|
| Email |
drsushmasri@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Academy of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Drsushmakrishnegowda |
| Address |
JSS Medical College, Mysuru |
| 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 |
| DrsushmaK |
JSS Hospital |
Department of Pediatrics, NICU,
2nd Floor,
Agrahara Mysuru
Mysore
KARNATAKA |
9742299896
drsushmasri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
| Intervention |
Close range immersive phototherapy device |
Phototherapy is given by close range immersive phototherapy device |
| Comparator Agent |
conventional phototherapy |
phototherapy is given through conventional phototherapy device |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All stable neonates with hyperbilirubinemia requiring phototherapy. |
|
| ExclusionCriteria |
| Details |
Babies who are sick on mechanical ventilation, requiring inotropes and babies requiring exchange transfusion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in bilirubin levels by 5% |
6 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/08/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Jaundice occurs in more than 85% of new-borns during the first days of life. Significant increase in free bilirubin levels are usually toxic and cause damage to the development of the central nervous system. Phototherapy, exchange transfusion and pharmacological agents are the different mode of treatment for hyperbilirubinemia. Phototherapy is one of the commonly used non-invasive mode of treatment. The most effective light source to degrade bilirubin is at a wavelength between 420 and 460 nanometers. The blue – green spectrum emitting light at required wavelength and irradiance are considered to be more effective to be used in phototherapy. Though Blue light phototherapy has been used frequently for management of hyperbilirubinemia, studies have shown many side effects of blue light. Continuous exposure to blue light was noticed to have various side effects like dry eyes, blurring, headache altered circadian rhythm causing disruption in sleep cycle and performance. With blue light causing these side effects, with the intention of preventing unnecessary exposure of health care personnel to blue light used during neonatal phototherapy, a close-range immersive phototherapy (CRimP) unit was devised to contain the spread of blue light. This study aims to compare the efficacy of CRimP against the standard phototherapy. |