Hypoxic challenge test in preterm infants

Conditions: Bronchopulmonary dysplasiaPrematurityPulmonary hypertensive disorders

Registration Number: NL-OMON25183

Lead Sponsor: Performer: Erasmus MC - Sophia Childrens Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Born < 30 weeks gestation

- Diagnosis of:
o Severe BPD: =28 days of supplemental oxygen requirement at 36 weeks postmenstrual age and need for supplemental oxygen >30% and/or positive pressure (invasive ventilation, CPAP or HFNC) OR
o Mild-moderate BPD: =28 days of supplemental oxygen requirement at 36 weeks postmenstrual age and breathing room air (mild) or need for <30% supplemental oxygen (moderate) OR
o No BPD: <28 days of supplemental oxygen requirement at 36 weeks postmenstrual age

- 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
The primary objective of this study is to investigate the predictive value of the hypoxic challenge test for respiratory morbidity (i.e. hypoxia in respiratory infections and need for hospital admission) in the six months following the test.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives of this study are:<br><br>- The relation of the HCT result and presence of pulmonary hypertension.<br>- Success/failure rate of the hypoxic challenge test (percentage of children that succeed or fail the test)<br>- Differences between groups (severe, mild-moderate or no BPD)<br>- Degree of right ventricular function related to the HCT outcome<br>- Polysomnography outcomes (Apnoea Hypopnoea Index (AHI), Oxygen Desaturation Index (ODI), mean saturation) and CT-scan score (% normal lung tissue, % hypo- and hyperattentuation, as assessed by PRAGMA BPD score) related to the HCT outcome.