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Recruiting NCT04114435

Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants

Observational Prematurity; Extreme

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiography.
Who it may be relevant to
Registry conditions: Prematurity; Extreme. Basic parameters: 7 Days — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants: A Prospective Cross-sectional Study

Overview

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

Detailed 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.

Interventions

  • Other Echocardiography
    Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures

Primary outcome measures

  • Heart function by echocardiography [Time frame: 7-10 days of chronological age]
  • Heart function by echocardiography [Time frame: 35-37 weeks post-menstrual age]
  • Heart function by echocardiography [Time frame: 39-44 weeks PMA]
  • Heart function by echocardiography [Time frame: 4 months PMA]
  • Heart function by echocardiography [Time frame: 9 months PMA]
  • Heart function by echocardiography [Time frame: 36 months PMA]
  • Heart function by echocardiography [Time frame: 5 years chronological]
Secondary outcome measures (7)
  • Neuro-developmental profile [Time frame: 7-10 days of chronological age]
  • Neuro-developmental profile [Time frame: 35-37 weeks post-menstrual age]
  • Neuro-developmental profile [Time frame: 39-44 weeks PMA]
  • Neuro-developmental profile [Time frame: 4 months PMA]
  • Neuro-developmental profile [Time frame: 9 months PMA]
  • Neuro-developmental profile [Time frame: 36 months PMA]
  • Neuro-developmental profile [Time frame: 5 years chronological]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Mcgill University Health Centre — Montreal

Identifiers

NCT: NCT04114435 · 2020-5893

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗