Clinical trial NCT04114435: Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants
Official title: Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants: A Prospective Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prematurity; Extreme
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 150
Sex: ALL
Minimum age (years): 7
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extreme premature newborns (\<29 weeks)

Brief summary: 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.

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).

Primary outcomes:
measure: Heart function by echocardiography
timeFrame: 7-10 days of chronological age
measure: Heart function by echocardiography
timeFrame: 35-37 weeks post-menstrual age
measure: Heart function by echocardiography
timeFrame: 39-44 weeks PMA
measure: Heart function by echocardiography
timeFrame: 4 months PMA
measure: Heart function by echocardiography
timeFrame: 9 months PMA
measure: Heart function by echocardiography
timeFrame: 36 months PMA
measure: Heart function by echocardiography
timeFrame: 5 years chronological
Secondary outcomes:
measure: Neuro-developmental profile
timeFrame: 7-10 days of chronological age
measure: Neuro-developmental profile
timeFrame: 35-37 weeks post-menstrual age
measure: Neuro-developmental profile
timeFrame: 39-44 weeks PMA
measure: Neuro-developmental profile
timeFrame: 4 months PMA
measure: Neuro-developmental profile
timeFrame: 9 months PMA
measure: Neuro-developmental profile
timeFrame: 36 months PMA
measure: Neuro-developmental profile
timeFrame: 5 years chronological
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Mcgill University Health Centre
state: Quebec
Study officials:
References: