Hypoxic challenge test in preterm infants

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25183

Enrollment

Registered

2019-05-21

Start date

2019-07-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary dysplasia Prematurity Pulmonary hypertensive disorders

Interventions

Children born <30 weeks gestational age with mild-moderate, severe or no BPD will undergo a hypoxic challenge test in a bodyplethysmograph at six months corrected age. The test is preceded by a cardia

Eligibility

Inclusion criteria

Inclusion criteria: - Born 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary objectives of this study are: - The relation of the HCT result and presence of pulmonary hypertension. - Success/failure rate of the hypoxic challenge test (percentage of children that succeed or fail the test) - Differences between groups (severe, mild-moderate or no BPD) - Degree of right ventricular function related to the HCT outcome - 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.	—

Measure

Time frame

Secondary objectives of this study are: - The relation of the HCT result and presence of pulmonary hypertension. - Success/failure rate of the hypoxic challenge test (percentage of children that succeed or fail the test) - Differences between groups (severe, mild-moderate or no BPD) - Degree of right ventricular function related to the HCT outcome - 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.

—

Contacts

Public ContactStephanie Balink

Erasmus MC - Sophia Kinderziekenhuis

sosbpd@erasmusmc.nl0650033994

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)