ong-term Outcome of Bronchopulmonary Dysplasia * Focus on Cardiovascular Health

Completed

Conditions: cardiovascular health
chronic lung disease in premature babies
10019280
10028971

Registration Number: NL-OMON47123

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 76

Inclusion Criteria

1. Healthy control group (n<=36; 16 for Part A, 20 for Part B); Young adults born a term at a gestational age * 37 weeks, age 18-25 years. For Part B, if possible, siblings of the participants of the preterm or BPD group are asked to participate to reduce potential lifestyle and socio-economic confounding effects.
2. Preterm group (n<=20, for Part B); Young adults born prematurely at a gestational age * 30 weeks, not diagnosed with BPD in the neonatal phase, age 18-25 years.
3. BPD group (n<=20, for Part B); Young adults born prematurely at a gestational age * 30 weeks, diagnosed with BPD in the neonatal phase, age 18-25 years. BPD is defined as oxygen dependency 28 days after birth. The severity of disease depends on the need of oxygen at 36 weeks of corrected gestational age; mild BPD no supplemental oxygen at 36-week, moderate BPD * 30% of supplemental oxygen, and severe BPD mechanical ventilation and/or oxygen >30 %.

Exclusion Criteria

- Known acquired or congenital hemodynamically significant heart disease (except heart disease as a consequence of pulmonary hypertension)
- Pulmonary disorders other than BPD
- Kidney disorders
- Neurodevelopmental disabilities that would prevent cooperation with CPET and/or CMR imaging.
- Absence of written informed consent

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A: MR cardiopulmonary exercise protocol validation:<br /><br>The main study parameter is the increase in oxygen consumption of subjects in<br /><br>relation to workload increase during a exercise test on a MR-ergometer and on a<br /><br>conventional ergometer.<br /><br><br /><br>Part B: CMR exercise study:<br /><br>The main study parameter is stroke volume of the right ventricle. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part A: MR cardiopulmonary exercise protocol validation:<br /><br>Other parameters are maximal heart frequency, CO2 production, respiratory<br /><br>coefficient.<br /><br><br /><br>Part B: CMR exercise study:<br /><br>Other study parameters are exercise capacity (peak oxygen uptake, VO2max) and<br /><br>several parameters for assessment of lung function (forced expired volume in 1<br /><br>second, FEV, total lung capacity, TLC, fractional residual capacity, FRC,<br /><br>diffusion capacity for carbon monoxide, DLCO), and assessment of cardiac<br /><br>function and structure (e.g. heart ventricular mass/volume ratio, tricuspid<br /><br>regurgitation velocity, heart ventricular longitudinal strain and ejection<br /><br>fraction). </p><br>