Supplemental oxygen strategies in children with bronchopulmonary dysplasia (BPD) after the neonatal intensive care unit: the SOS BPD study.
Recruiting
- Conditions
- bronchopulmonary dysplasiachronic lung disease of prematurity10028971
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 198
Inclusion Criteria
- born < 32 weeks of gestational age - oxygen need for >= 28 days from birth
until 36 weeks of PMA - moderate or severe BPD at 36 weeks postmenstrual age
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
- retinopathy of prematurity for which the ophthalmologist recommended a
patient specific SpO2 target
- congenital malformations of the lung or airways
- severe acquired upper airway abnormalities like subglottic stenosis
necessitating endotracheal intubation
- interstitial lung disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to investigate if targeting a higher<br /><br>SpO2 (i.e. 95% lower limit) leads to superior growth of normal lung tissue<br /><br>(assessed indirectly by body weight) at 6 months corrected age as compared to<br /><br>targeting a lower SpO2 (90% lower limit) in children with moderate-severe BPD<br /><br>from 36 weeks PMA and onwards.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are:<br /><br><br /><br>- body weight and height at 12 months corrected age<br /><br>- health care consumption (visits to helath care professionals, admissions)<br /><br>- quality of life of the parents or caregivers.<br /><br><br /><br>In a subgroup of children:<br /><br>- lung function (lung clearance index)<br /><br>- chest CT scores<br /><br>- pulmonary hypertension and/or right ventricle systolic function. </p><br>