NCT04114435

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

October 12, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

4.1 years

First QC Date

October 1, 2019

Last Update Submit

June 12, 2025

Conditions

Prematurity; Extreme

Outcome Measures

Primary Outcomes (7)

  • Heart function by echocardiography

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

    7-10 days of chronological age

  • Heart function by echocardiography

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

    35-37 weeks post-menstrual age

  • Heart function by echocardiography

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

    39-44 weeks PMA

  • Heart function by echocardiography

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

    4 months PMA

  • Heart function by echocardiography

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

    9 months PMA

  • Heart function by echocardiography

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

    36 months PMA

  • Heart function by echocardiography

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

    5 years chronological

Secondary Outcomes (7)

  • Neuro-developmental profile

    7-10 days of chronological age

  • Neuro-developmental profile

    35-37 weeks post-menstrual age

  • Neuro-developmental profile

    39-44 weeks PMA

  • Neuro-developmental profile

    4 months PMA

  • Neuro-developmental profile

    9 months PMA

  • +2 more secondary outcomes

Study Arms (3)

Neonatal profile

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

Other: Echocardiography

Infant profile ( between 4 months and 9 months)

* Echocardiography * Ages \& stages questionnaires CAT/CLAMS assessment

Other: Echocardiography

Pediatric profile (36 months and 5 years)

* Echocardiography * Ages \& stages questionnaires CAT/CLAMS assessment * Results from 18 months PMA Bayley will be retrieved Figure 1: Premature population - Groups Recruited simultaneously

Other: Echocardiography

Interventions

EchocardiographyOTHER

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

Infant profile ( between 4 months and 9 months)Neonatal profilePediatric profile (36 months and 5 years)

Eligibility Criteria

Age7 Days - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Extreme premature newborns (\<29 weeks)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mcgill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 3, 2019

Study Start

October 12, 2019

Primary Completion

November 30, 2023

Study Completion

December 1, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)