Status:

COMPLETED

Novel Echocardiographic Methods for Early Identification of Neonates at Risk for Chronic Pulmonary Hypertension

Lead Sponsor:

Mount Sinai Hospital, Canada

Collaborating Sponsors:

Sunnybrook Health Sciences Centre

Liverpool Women's NHS Foundation Trust

Conditions:

Pulmonary Hypertension

Infant, Premature

Eligibility:

All Genders

14+ years

Brief Summary

Chronic pulmonary hypertension (cPHT) is a serious cardiopulmonary disorder that causes low oxygen levels in the blood, difficulty in breathing and ultimately heart failure. Newborn babies born extrem...

Detailed Description

This is a multi-centre prospective observational study to develop new quantitative echocardiography diagnostic criteria sensitive to identify the presence of chronic pulmonary hypertension early in po...

Eligibility Criteria

Inclusion

  • Gestational age at birth ≤26+6/7 and/or birth weight \<1000g
  • Alive at two weeks of postnatal age
  • Infant cleared by the clinical team for approach

Exclusion

  • Known major congenital and/or genetic anomaly
  • Congenital heart defects (CHD) except patent ductus arteriosus (PDA), patent foramen ovale (PFO), peripheral pulmonary artery stenosis and small (\< 3 mm in diameter) ventricular septal defects
  • Any condition which, in the opinion of the investigator, would preclude enrollment

Key Trial Info

Start Date :

August 31 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2024

Estimated Enrollment :

350 Patients enrolled

Trial Details

Trial ID

NCT04402645

Start Date

August 31 2017

End Date

April 1 2024

Last Update

June 14 2024

Active Locations (6)

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Page 1 of 2 (6 locations)

1

University of Iowa Health Care

Iowa City, Iowa, United States, 52242

2

BC Women's Hospital & Health Centre

Vancouver, British Columbia, Canada, V6H 3N1

3

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

4

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G 1X5