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

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

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.