Bronchopulmonary dysplasia Chronic Lung Disease Respiratory Distress
Conditions
Interventions
Participating infants treated with the intention to manage the infant with
non-invasive respiratory support (day 0-7) ór after extubation (day 1-28) will
be randomised to non-invasive respiratory su
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Gestational age less than 30 weeks Birthweight less than 1 kg Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube) whether A. primairy: within the first 7 days of life and the infant has never been intubated or has received less than 24 hours of intubated respiratory support (e.g. for endotracheal surfactant therapy /INSURE:intubate-surfactant replacement therapy-extubate) OR B. secondary:the infant is within the first 28 days of life, has been managed with intubated respiratory support for more than 24 hours and is a candidate for extubation followed by non-invasive respiratory support.
Exclusion criteria
Exclusion criteria: 1. Considered Non-viable by attending physician 2. Life-threatening congenital abnormalties including congenital heart disease (exl patent ductus arteriosus) 3. Infants known to require surgical treatmene e.g. congenital diaphragmatic hernia, tracheo-oesophageal fistula, omphalocele and gastroschisis. 4. Abnormalties of the upper and lower airways; such as Pierre-Robin sequence, Treacher Collins syndrome, Goldenhar syndrome, cleft lips and palate. 5. Neuromuscular disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite primary outcome is BPD-free-survival. The oxygen reduction test is used to assess BPD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are mortality at 36 weeks, BPD at 36 weeks, other respiratory parameters, and complications of prematurity such as NEC, ROP, IVH, infections. Cost-effectiveness analyses. | — |
Countries
Netherlands
Outcome results
None listed