The hypoxic challenge test in preterm infants with or without bronchopulmonary dysplasia: a test for pulmonary and pulmonary vascular function?

Recruiting

Conditions: Vroeggeboorte
chronic lung disease of prematurity. Pulmonary hypertension
high bloodpressure in the blood vessels of the lung.
Prematurity
preterm birth. Bronchopulmonary dysplasia
10028971
10057166

Registration Number: NL-OMON52578

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Born <32 weeks gestation
- Diagnosis of:
== Severe BPD, or
== Mild-moderate BPD, or
== No BPD
- Included in the long term neonatal or BPD follow up program of Erasmus MC
- Written informed consent by parents and/or caregivers

Exclusion Criteria

- Current supplemental oxygen requirement
- Congenital heart disease with hemodynamic consequences
- Pulmonary hypertension requiring medication
- Significant respiratory disease other than BPD

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are the predictive value of the test to predict respiratory<br /><br>morbidity (i.e. hypoxia during respiratory infections and need for hospital<br /><br>admission) in the six months following the test. Also the relation of the HCT<br /><br>result and presence of pulmonary hypertension is one of the primary endpoints.<br /><br>. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are success and failure rate (not passing the test) per<br /><br>group, and degree of pulmonary hypertension, right ventricular function, chest<br /><br>CT score and polysomnography outcomes related to the HCT result. </p><br>