| CTRI Number |
CTRI/2024/07/070378 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
to check the effect of bilirubin and albumin ratio with duration of phototherapy |
|
Scientific Title of Study
|
A prospective study of association of bilirubin and albumin ratio on the immediate outcome of neonatal hyperbilirubinemia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Bhavani M |
| Designation |
MD Paediatrics |
| Affiliation |
Datta Meghe Institute of Medical sciences, Wardha |
| Address |
2nd floor ,Department of Neonatology, Shalinitai Meghe Super-specialty Hospital, AVBRH Campus
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9741797985 |
| Fax |
|
| Email |
sai.bhavani8525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R J Meshram |
| Designation |
associate professor |
| Affiliation |
Datta Meghe Institute of Medical sciences, Wardha |
| Address |
2nd floor, Department of Paediatrics, Shalinitai Meghe Super-specialty Hospital, AVBRH Campus
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
98237639889 |
| Fax |
|
| Email |
rjmeshram@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R J Meshram |
| Designation |
associate professor |
| Affiliation |
Datta Meghe Institute of Medical sciences, Wardha |
| Address |
2nd floor, Department of Paediatrics, Shalinitai Meghe Super-specialty Hospital, AVBRH Campus
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
98237639889 |
| Fax |
|
| Email |
rjmeshram@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education And Research , Sawangi Meghe , Wardha, Maharashtra,India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
department of paediatrics , 2nd floor, Sawangi Meghe, Wardha, Maharashtra ,India, 442001 |
| 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 |
| Dr Sai Bhavani |
Jawaharlal Nehru Medical College |
Department Of Neonatology , 2nd Floor , Acharya Vinoba Bhave Rural Hospital , Jawaharlal Nehru Medical College
Wardha
MAHARASHTRA |
9741797985
sai.bhavani8525@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All the Neonates admitted in NICU receiving phototherapy for hyperbilirubinemia after 24 hours of life.
|
|
| ExclusionCriteria |
| Details |
Neonates with Conjugated Hyperbilirubinemia.
Neonates with co-morbidities like acute renal failure, Hydrops foetalis, congenital nephritic syndrome, and other diseases that mimic BIND as well as death due to other reasons |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of phototherapy significantly correlates to the bilirubin and albumin ratio |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
12/07/2024 |
| 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="0"
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 jaundice is one of the most common issues of neonates.THE incidence of neonatal jaundice in India varies from 54.6% to 77% .
Although mostly physiological, sometimes it can result in irreversible bilirubin encephalopathy if not recognised, which becomes the concern factor for a developing brain. Out of various treatment modalities available for neonatal jaundice, phototherapy is widely used.
The study will be carried out in neonates with clinical jaundice requiring phototherapy and admitted to the neonatal intensive care unit (NICU) both inborn & outborn of AVBRH, Datta Meghe Institute of Higher Education and Research. The neonates satisfying the inclusion criteria will be included in the study after procuring consent from the parents on a pre-validated informed consent proforma. All the babies after 24 hours of life will be screened for Neonatal Jaundice using total serum bilirubin values.Newborns with Conjugated Hyperbilirubinemia, co-morbidities like acute renal failure, Hydrops foetalis, congenital nephritic syndrome, and other diseases that mimic BIND as well as death due to other reasons will be excluded from the study. If albumin levels are normalised in the initial phases of treatment for neonatal hyperbilirubinemia , the neurological impact can be reduced.
|