Extra zuurstof bij kinderen met bronchopulmonale dysplasia (BPD) na de neonatale intensive care periode: de SOS BPD studie

Supplemental Oxygen Strategies in children with Bronchopulmonary dysplasia (BPD) after the neonatal intensive care unit: the SOS BPD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20710

Enrollment

196

Registered

2018-07-10

Start date

2018-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

bronchopulmonary dysplasia (BPD) supplemental oxygen oxygen saturation target growth In Dutch: bronchopulmonale dysplasie extra zuurstof saturatie grens groei

Interventions

Children with moderate-severe BPD from 36 weeks PMA and onwards, receiving supplemental oxygen, will be randomized with two parallel arms: 1. weaning of supplemental oxygen based on SpO2 lower limi

95% 2. weaning of supplemental oxygen based on SpO2 lower limit &#8805

90%.

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 objectives of this study are: - 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. - To determine if a strategy aiming at a lower limit of SpO2 of >= 95% is cost-effective. In a subgroup of children: - 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. - 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.	—

Measure

Time frame

Secondary objectives of this study are: - 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. - To determine if a strategy aiming at a lower limit of SpO2 of >= 95% is cost-effective. In a subgroup of children: - 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. - 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.

—

Contacts

Public ContactM.H.W. Pijnenburg

Erasmus Medical Center, Sophia Children’s Hospital, Department of Pediatric Pulmonology Dr. Molenwaterplein 60

m.pijnenburg@erasmusmc.nl+31 (0)10-4636263

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)