| CTRI Number |
CTRI/2024/04/066226 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A questionnaire for practising Indian neonatologists to review current practices of treatment in neonates with hypoxic ischemic encephalopathy after the release of guidelines by National Neonatology Forum. |
|
Scientific Title of Study
|
Impact of National Neonatology Forum position statement on cooling for babies with Hypoxic Ischemic Encephalopathy in India: A Survey of National Practices |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reema Garegrat |
| Designation |
Consultant |
| Affiliation |
Gupta Neonatal hospital and Perinatal Brain Research Centre |
| Address |
Floor 1,
Department of Neonatology,
Gupta Neonatal hospital and Perinatal brain research centre,
43-W, Opposite Pushpa Complex, Model Town, Hisar
Hisar
HARYANA
125001
India |
| Phone |
|
| Fax |
|
| Email |
reemas532@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reema Garegrat |
| Designation |
Consultant |
| Affiliation |
Gupta Neonatal Hospital and Perinatal Brain research Centre |
| Address |
Floor 1,
Department of Neonatology,
Gupta Neonatal hospital and Perinatal brain research centre,
43-W, Opposite Pushpa Complex
Hisar
HARYANA
125001
India |
| Phone |
9819588972 |
| Fax |
|
| Email |
reemas532@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reema Garegrat |
| Designation |
Consultant |
| Affiliation |
Gupta Neonatal Hospital and Perinatal Brain research Centre |
| Address |
Floor 1,
Department of Neonatology,
Gupta Neonatal hospital and Perinatal brain research centre,
43-W, Opposite Pushpa Complex
HARYANA
125001
India |
| Phone |
9819588972 |
| Fax |
|
| Email |
reemas532@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gupta Neonatal Hospital and Perinatal Brain Research Centre,
Floor 1, Department of Neonatology,
43-W, Opposite Pushpa Complex,
Hisar, Haryana |
|
|
Primary Sponsor
|
| Name |
Reema Garegrat |
| Address |
Floor1,Department of Neonatology,
Gupta Neonatal Hospital and Perinatal Brain Research Centre,
43-W, Opposite Pushpa Complex,Model Town,Hisar-125001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Reema Garegrat |
Gupta Neonatal Hospital and Perinatal Brain Research Centre |
Floor 1,
Department of Neonatology,
Opposite Pushpa Complex,
Model Town
Hisar
HARYANA |
9819588972
reemas532@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aadhar Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Clinicians |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All practising neonatologists will be eligible to participate in this survey |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. change in clinical practice in Indian neonatal units and
guidelines. |
3 weeks after survey administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.if clinicians are adhering to the NNF |
3 weeks after survey administration |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/05/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
We will conduct a prospective cross sectional survey involving all Indian neonatal units. We will identify potential participants using the online listing of all level1, level2 (an and b) and level 3 neonatal intensive care units in hospitals across India on the national neonatology forum database. We will use a 21-part questionnaire using multiple choice or dichotomous questions (Qualtrics survey tool) that will be communicated via a web based messenger service with an individualised link to the survey to the lead clinicians of the eligible centres. The lea clinician of the neonatal unit will be contacted over telephone if there will be no response to two rounds of reminders via message. The survey will remain open for one month and a reminder email will be sent regularly. |