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Clinical Trials/CTRI/2024/07/070994
CTRI/2024/07/070994Not yet recruitingNot Applicable

Echocardiographic abnormalities in very preterm babies requiring cardiorespiratory support- a prospective observational study

Kerala Institute of Medical Sciences1 site in 1 country150 target enrollmentStarted: August 3, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
150
Locations
1
Primary Endpoint
Proportions of echocardiographic studies with abnormalities

Study Overview

Brief Summary

All preterm babies (less than 32 weeks of gestation) requiring cardiorespiratory support will be included in the study. Functional echocardiography will be performed by a neonatologist trained in cardiac echocardiography within 24 hours starting of cardiorespiratory support in the first week of life. Results of the echo will be confirmed by a pediatric cardiologist.Parameters like left ventricular output, right ventricular output, mitral valve EA ratio, fractional shortening, inferior vena cava collapsibility index, PDA assessment, tricuspid regurgitation, TAPSE and septal motion will be documented in each echo examination. Echo findings will be compared with the hemodynamic status of each baby at that point of time. If any abnormal echo findings is documented that baby will be followed up by a repeat echo after 24 hrs. Any change in management plan done based on the echocardiographic findings if done will also be noted. Unit.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
0.00 Day(s) to 7.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • 1.Very Preterm babies requiring cardiorespiratory support 2.Very preterm babies requiring upgradation in respiratory support in the first week of life.

Exclusion Criteria

  • Preterm babies not requiring cardiorespiratory support Babies with lethal congenital anomalies.

Outcomes

Primary Outcomes

Proportions of echocardiographic studies with abnormalities

Time Frame: 3monnths, 6 months, 9months, 12months, 15 months, 18 months

Secondary Outcomes

  • 1.(The proportion of babies abnormal echocardiographic findings having hemodynamic instability)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Asha P T

Kerala Institute Of Medical Sciences, Kerala

Study Sites (1)

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