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Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants

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McGill University

Status

Enrolling

Conditions

Prematurity; Extreme

Treatments

Other: Echocardiography

Study type

Observational

Funder types

Other

Identifiers

NCT04114435
2020-5893

Details and patient eligibility

About

Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study

Full description

The principal investigator hypothesize that premature newborns have disturbed cardiac performance and increased pulmonary pressures during neonatal life and at different pediatric ages.

The principal investigator also hypothesize that premature newborns with poor cardiac performance and/or pulmonary hypertension have higher morbidities and poorer neuro-developmental outcomes.

The principal investigator also hypothesize that premature newborns with poor cardiac performance and/or pulmonary hypertension have higher morbidities and poorer neuro-developmental outcomes and that novel echocardiography techniques will detect anomalies not uncovered by conventional imaging, and that early echocardiography may identify those with later pulmonary hypertension.

Enrollment

150 estimated patients

Sex

All

Ages

7 days to 5 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Infants born at <29 weeks' gestational age admitted to the NICU
  • All infants born at <29 weeks' gestational age followed at MCH clinic after an admission in the NICU for prematurity <29 weeks

Exclusion criteria

  • Congenital heart disease (except an atrial (ASD) or ventricular septal defect (VSD), or a patent ductus arteriosus (PDA))
  • Congenital severe lung or airway malformation (choanal atresia, trachea-esophageal fistula or congenital pulmonary airway malformation)
  • Genetic disorder (Trisomy 21).

Trial design

150 participants in 3 patient groups

Neonatal profile
Description:
Echocardiography at: * 7 to 10 days of chronological age * 35 to 37 weeks post-menstrual age (PMA = corrected age); * 39 to 44 weeks PMA; Term equivalent
Treatment:
Other: Echocardiography
Infant profile ( between 4 months and 9 months)
Description:
* Echocardiography * Ages \& stages questionnaires CAT/CLAMS assessment
Treatment:
Other: Echocardiography
Pediatric profile (36 months and 5 years)
Description:
* Echocardiography * Ages \& stages questionnaires CAT/CLAMS assessment * Results from 18 months PMA Bayley will be retrieved Figure 1: Premature population - Groups Recruited simultaneously
Treatment:
Other: Echocardiography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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