| CTRI Number |
CTRI/2024/05/066779 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
validation study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Handheld Doppler and Electrocardiogram Accuracy in Neonatal Heart Rate Assessment During Resuscitation |
|
Scientific Title of Study
|
Evaluation Of Handheld Dopplers Accuracy For Heart Rate Assessment Versus Electrocardiogram During Neonatal Resuscitation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Arjun Kumar |
| Designation |
DM resident neonatology |
| Affiliation |
Sri Ramachandra institute of medical sciences |
| Address |
Department of neonatology
,porur, chennai
Chennai
TAMIL NADU
600056
India |
| Phone |
9642097679 |
| Fax |
|
| Email |
arjun.m90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prakash A |
| Designation |
Prof Neonatology |
| Affiliation |
Sri Ramachandra institute of medical sciences |
| Address |
Department of Neonatology, porur
chennai
Chennai
TAMIL NADU
600056
India |
| Phone |
|
| Fax |
|
| Email |
hod.neonatology@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
M Arjun Kumar |
| Designation |
DM resident neonatology |
| Affiliation |
Sri Ramachandra institute of medical sciences |
| Address |
department of Neonatology, porur
chennai
TAMIL NADU
600056
India |
| Phone |
9642097679 |
| Fax |
|
| Email |
arjun.m90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramchandra institute of higher education and research
porur, chennai, 600056, tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Sri Ramchandra institute of higher education and research |
| Address |
Sri Ramchandra institute of higher education and research, mount ponnamalle road, Porur, Chennai, Tamil Nadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| M Arjun Kumar |
Sri Ramchandra institute of higher education and research |
department of Neonatology, 3rd floor, Mount Ponnamalle Road, porur, chennai, Tamil Nadu
Chennai
TAMIL NADU |
9642097679
arjun.m90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institutional Research Ethics Committee |
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 |
| Comparator Agent |
Multipara monitor |
heart rate from ECG of multipara monitor compared with handheld doppler |
|
|
Inclusion Criteria
|
| Age From |
32.00 Day(s) |
| Age To |
41.00 Day(s) |
| Gender |
Both |
| Details |
Moderate to Late Preterm: 32 0/7–36 6/7 and Term Newborns: 37 0/7–41 6/7 weeks of gestational age undergoing caesarean deliveries at SRMC |
|
| ExclusionCriteria |
| Details |
Skin lesions pose difficulty attaching ECG leads and placing the Doppler probe.
If not able to record heart rate with ECG or pulse-oximeter.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the accuracy of early detection of heart rate using handheld Doppler in comparison to ECG |
baseline at time of birth to 120 seconds for normal and 300 seconds for babies requiring resucitation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine the average time it takes to achieve a neonatal heart rate through different methods. |
baseline at time of birth to 120 seconds for normal & 300 seconds for babies requiring resucitation |
| Record the time needed for applying various approaches in heart rate assessment |
from time of application to time of first initial record of values displayed measured in seconds |
| Evaluate the effectiveness & practicality of using a handheld Doppler for neonatal heart rate measurement in comparison to ECG & Pulse oximetry |
baseline heart rate measurements done over a period of 120 seconds in normal babies & 300 seconds for babies requiring resuscitation using Bland-Altman analysis for comparison |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/05/2024 |
| 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="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
|
Three-lead electrocardiography (ECG) identifies neonatal heart rate more rapidly and accurately and is the gold standard as per neonatal resuscitation guidelines. So, determining whether measuring heart rate using a handheld Doppler is an adjunct device with efficacy like an ECG during neonatal resuscitation will pave the way forward as the first line of measuring in low- resource settings and be easily operable by any trained responder in handling newborn deliveries. |