Extra zuurstof bij kinderen met bronchopulmonale dysplasia (BPD) na de neonatale intensive care periode: de SOS BPD studie
- Conditions
- bronchopulmonary dysplasia (BPD)supplemental oxygenoxygen saturation targetgrowthIn Dutch:bronchopulmonale dysplasieextra zuurstofsaturatie grensgroei
- Registration Number
- NL-OMON20710
- 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
- 196
Inclusion Criteria
born < 32 weeks of gestational age
- oxygen need for >= 28 days from birth until 36 weeks of PMA
Exclusion Criteria
- Significant congenital heart disease (not being persisting ductus arteriosus, small atrial septal defect, ventricular septal defect)
- pulmonary hypertension treated with sildenafil or bosentan
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to investigate if targeting a higher SpO2 (i.e. 95% lower limit) leads to superior growth of normal lung tissue (assessed indirectly by body weight) at 6 months corrected age as compared to targeting a lower SpO2 (90% lower limit) in children with moderate-severe BPD from 36 weeks PMA and onwards
- Secondary Outcome Measures
Name Time Method Secondary objectives of this study are: <br /><br /><br><br> - To determine if targeting a higher SpO2 (i.e. 95% lower limit) translates into better body weight and height at 12 months corrected age, less health care consumption and better quality of life of the parents or caregivers.<br><br /><br /><br> - To determine if a strategy aiming at a lower limit of SpO2 of >= 95% is cost-effective. <br><br /><br /><br> In a subgroup of children:<br /><br>- To determine if a strategy aiming at a lower limit of SpO2 of >= 95% translates into better lung function (lower lung clearance index) and/or better lung structure as assessed with CT scans. <br><br /><br /><br>- To determine if a strategy aiming at a lower limit of SpO2 of >= 95% translates into less pulmonary hypertension and/or better right ventricle systolic function.