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Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2017/03/008241
Date of registration:	28-03-2017
Prospective Registration:	Yes
Primary sponsor:	none
Public title:	To compare the time to get heart rate by two methods in newborn babies
Scientific title:	Comparison of heart rate accuracy and acquisition time using hand held Doppler with ECG post delivery - A prospective observational study - HRCOM
Date of first enrolment:	01-04-2017
Target sample size:	350
Recruitment status:	Completed
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16719
Study type:	Observational
Study design:	Single Arm Trial Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded
Phase:	Phase 1

Countries of recruitment
India

Contacts

Name:	Sanjay Wazir
Address:	Department of Pediatrics and Neonatology Cloud 9 Hospital, Plot No. A-2, MSJ House, Mayfield Garden sector 47, Gurgaon Department of Pediatrics and Neonatology Cloud 9 Hospital, Plot No. A-2, MSJ House, Mayfield Garden sector 47, Gurgaon 122018 Gurgaon, HARYANA India
Telephone:
Email:	swazir21@gmail.com
Affiliation:	Cloud 9 Hospital

Name:	Raktima Chakrabarti
Address:	T4/1402, Escape, Golf Course Ext Road, Sector 50 Department of Pediatrics and Neonatology Cloud 9 Hospital, Plot No. A-2, MSJ House, Mayfield Garden sector 47, Gurgaon 122018 Gurgaon, HARYANA India
Telephone:
Email:	swazir21@gmail.com
Affiliation:	Cloud 9 Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. All newly born babies more than 34 weeks delivered by LSCS
Exclusion criteria: 1. prenatally diagnosed congenital anomaly

2. babies with suspected genetic abnormality

3. Babies with congenital skin disorders

4. Congenital heart block and any antenatally diagnosed arrythmia.

5. <34 weeks gestation

6. Sick Babies

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Intervention(s)

Primary Outcome(s)

Accuracy of Heart rate calculated by Hand held Doppler compared to ECG in neonates immediately (3 seconds) after delivery. secondTimepoint: Accuracy of Heart rate calculated by Hand held Doppler compared to ECG in neonates 3 seconds after delivery

Secondary Outcome(s)

1. Difference in the time required to detect a meaningful signal after birth (two times interval to be calculated â?? time between the application of device to the baby and time from birth to get a meaningful signal from the baby.

2. Does the device work differently in different gestations(34-37 weeks and more than 37 weeks)

3. Difficulty in maintaining signal from the baby and reapplication

Timepoint: 20 sec

Secondary ID(s)

NIL

Source(s) of Monetary Support

Cloud 9 Hospital, Plot No. A-2, MSJ House, Mayfield Garden sector 47, Gurgaon, Haryana.

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 09/03/2017
Contact:

Institutional Ethics Committee, Cloudnine Hospital, Bangalore

Results

Results available:
Date Posted:
Date Completed:	14/08/2017
URL:

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