Respiratory distress in preterm babies
Conditions
Interventions
Use of Biphasic CPAP or nasal CPAP (based on randomisation) soon after the baby is extubated from mechanical ventilation. Period of intervention first 72 hours post-extubation.
Sponsors
NHS Lanarkshire (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Babies born between 23 weeks and 0 days and 30 weeks and 6 days gestation who are supported with mechanical ventilation for at least 6 hours in the first 28 days of life (first episode of ventilation only)
Exclusion criteria
Exclusion criteria: Babies with any factor that may affect respiratory effort evident from the initial period, e.g.: 1. Neonatal encephalopathy (involvement of the brain with possible seizures, hypoxic ischaemic encephalopathy [HIE] stage 2 or 3, which is related to perinatal asphyxia) 2. Obvious major birth defects (congenital malformations) 3. Disorders of the muscular system with significant weakness (neuromuscular problems)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful extubation, defined as not meeting reintubation/extubation failure criteria until 72 hours after extubation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gastrointestnal (GI) complications 2. Total duration on ventilatory support 3. Incidence of Chronic Lung Disease (CLD) (defined as need for oxygen support beyond 28 days/36 weeks corrected gestational age) 4. Incidence and severity of intraventricular haemorrhage (IVH) 5. Time to full feeds | — |
Countries
United Kingdom
Outcome results
None listed