Published in:
Open Access 01-12-2011 | Study protocol
EXTUBATE: A randomised controlled trial of nasal biphasic positive airway pressure vs. nasal continuous positive airway pressure following extubation in infants less than 30 weeks' gestation: study protocol for a randomised controlled trial
Published in: Trials | Issue 1/2011
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Background
Respiratory distress syndrome remains a significant problem among premature infants. Mechanical ventilation through an endotracheal tube remains the mainstay of respiratory support but may be associated with lung injury and the development of chronic lung disease of prematurity. Efforts are needed to reduce the duration of mechanical ventilation in favour of less invasive forms of respiratory support and to improve rates of successful extubation.
Non-invasive respiratory support has been demonstrated to be less injurious to the premature lung. Standard practice is to use nasal continuous positive airway pressure (n-CPAP) following extubation to support the baby's breathing. Many clinicians also use nasal biphasic positive airway pressure (n-BiPAP) in efforts to improve rates of successful extubation. However, there is currently no evidence that this confers any advantage over conventional nasal continuous positive airway pressure.
Methods
We propose an unblinded multi-centre randomised trial comparing n-CPAP with n-BiPAP in babies born before 30 weeks' gestation and less than two weeks old. Babies with congenital abnormalities and severe intra-ventricular haemorrhage will be excluded. 540 babies admitted to neonatal centres in England will be randomised at the time of first extubation attempt. The primary aim of this study is to compare the rate of extubation failure within 48 hours following the first attempt at extubation. The secondary aims are to compare the effect of n-BiPAP and n-CPAP on the following outcomes:
1. Maintenance of successful extubation for 7 days post extubation
2. Oxygen requirement at 28 days of age and at 36 weeks' corrected gestational age
3. Total days on ventilator, n-CPAP/n-BiPAP
4. Number of ventilator days following first extubation attempt
5. pH and partial pressure of carbon dioxide in the first post extubation blood gas
6. Duration of hospital stay
7. Rate of abdominal distension requiring cessation of feeds
8. Rate of apnoea and bradycardia
9. The age at transfer back to referral centre in days
The trial will determine whether n-BiPAP is safe and superior to n-CPAP in preventing extubation failure in babies born before 30 weeks' gestation and less than two weeks old.
Trial registration number
ISRCTN: ISRCTN18921778