Respiratory distress syndrome Pregnancy and Childbirth Respiratory distress of newborn
Conditions
Interventions
Two modes of non-invasive ventilation:
1. Continuous positive airway pressure - active control
2. Synchronised intermittent positive airway pressure (SiPAP™) - intervention
Treatment will be until no
Sponsors
South Tees Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gestational age - 28+0 to 31+6 weeks by scan estimated date of delivery (EDD) inclusive 2. Signs of respiratory distress requiring non-invasive respiratory support 3. Inborn 4. Signed written parental consent for participation 5. Randomised by 6 hours of age or less
Exclusion criteria
Exclusion criteria: 1. Gestational age - less than 27+6 weeks or greater than 32+0 weeks 2. Endotracheal intubation and ventilation at any time prior to enrolment 3. Respiratory distress meeting failure criteria of non-invasive ventilation and requiring intubation and mechanical ventilation 4. Congenital or neuromuscular disorders diagnosed antenatally or at the time of birth, known to interfere with respiratory function or ability to breathe; including significant abnormalities of the upper airway 5. Refusal of signed written parental consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure of non-invasive ventilation necessitating intubation and mechanical ventilation (placement of a tube in the windpipe and full artificial breathing support via machine) in the first 72 hours of treatment with either CPAP or SiPAP™. This outcome is binary categoric as babies will be either 'intubated and mechanically ventilated' or not; providing a proportion of infants in each treatment arm who meet this outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed from the medical notes and nursing charts at discharge they all constitute usual care of preterm infants at these gestations, who are intensive care level patients and continuously monitored whilst receiving respiratory support. It is impossible to specify an exact timepoint for many of the outcomes as they can occur at any time for these infants, hence an assessment of the occurrence or not of the outcome on discharge by reviewing the case notes. 1. Death prior to discharge - at time of death 2. RDS severity grading - at randomisation 3. Reason for failure of non-invasive ventilation -at failure 4. Timing of failure of non-invasive ventilation - at failure 5. Total duration of any form of respiratory support - at discharge - review of notes 6. Duration of invasive mechanical ventilation - at discharge - review of notes 7. Duration of supplemental oxygen - at discharge - review of notes 8. Bronchopulmonary dysplasia (diagnosis) - at 36 weeks gestation 9. Pneumothorax (diagnosis) - at discharge - review of notes 10. Postnatal steroid use - at discharge - review of notes 11. Necrotising enterocolitis diagnosis - at discharge - review of notes 12. Necrotising enterocolitis needing surgery - at discharge - review of notes 13. Gastric distension - assessed clinically 6-8 hourly whilst on non-invasive ventilation, outcome assessed at discharge - review of notes 14. Sepsis diagnosis - at discharge - review of notes 15. Nasal injuries - assessed clinically 6 - 8 hourly whilst on non-invasive ventilation, outcome assessed at discharge - review of notes 16. Nasal injuries - grading and treatment required, at discharge - review of notes 17. Retinopathy of prematurity - greater than grading and treatment (surgery), at discharge - review of notes 18. Patent ductus arteriosus - greater than treatment required, at discharge - review of notes 19. Abnormal cranial ultrasound scan - report worst scan for grading, at discharge - review of notes 20. Cranial abnormalities pe | — |
Countries
United Kingdom
Outcome results
None listed