bronchopulmonary dysplasia chronic lung disease of prematurity
Conditions
Interventions
Besides from the two saturation targets, there are no other interventions.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: - born = 28 days from birth until 36 weeks of PMA - moderate or severe BPD at 36 weeks postmenstrual age
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary outcomes are: - body weight and height at 12 months corrected age - health care consumption (visits to helath care professionals, admissions) - quality of life of the parents or caregivers. In a subgroup of children: - lung function (lung clearance index) - chest CT scores - pulmonary hypertension and/or right ventricle systolic function. | — |
Countries
Netherlands
Contacts
Public ContactM.W.H. Pijnenburg
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed