Title: Randomised controlled trial of nasal biphasic positive airway pressure vs. nasal continuous positive airway pressure following extubation in infants less than 30 weeks gestation.
Funder: Department of Health (England)

Abstract: Background Respiratory distress syndrome is a significant problem in babies born before 34 weeks’ gestation. Mechanical ventilation through an endotracheal tube is associated with chronic lung injury. Efforts are needed to reduce the number of ventilator days using less invasive forms of assisted ventilation and improving rates of successful extubation. Non-invasive respiratory support has been demonstrated to be less injurious to the 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 another device called nasal biphasic positive airway pressure (n-BiPAP) as a means of improving rates of successful extubation and oxygenation. However, there is currently no evidence that it is effective. Aims The primary aim of this study is to compare the risk of extubation failures for 48 hours post-extubation with the use of n-BiPAP or n-CPAP in babies born before 30 weeks gestation and less than 2 weeks old. The secondary aims are to determine the effect of n-BiPAP in the same study group on the following: 1. Maintenance of successful extubation for 7 days post extubation 2. Oxygen requirement at 28 days of age and at term corrected gestational age 3. Total days on ventilator, n-CPAP/ n-BIPAP 4. Number of ventilator days following first extubation attempt 5. pH, partial pressure of carbon dioxide in the first post extubation blood gas 6. Duration of hospital stay 7. Rate of abdominal distension 8. Rate of apnoea and bradycardia 9. The age at transfer back to referral centre in days. Plan of Investigation An unblinded randomised trial will be conducted at three regional neonatal units in the north-west of England. 540 babies born before 30 weeks gestation and less than two weeks old will be randomised to receive either n-CPAP or n-BiPAP following the first attempt at extubation. The n-CPAP group will receive at extubation a CPAP of 6 cm water for at least 48 hours before weaning is commenced. The n-BiPAP group will receive at extubation a mean airway pressure of 6 cm water for at least 48 hours before weaning is commenced. Incidence of extubation failure for 48 hours post-extubation will be used as the primary outcome measure. The Research Parent Group has been formed. The group will help design, manage and disseminate the results of this study. Potential Impact The funding will allow us to conduct the first randomised controlled trial on n-BiPAP in premature babies. A successful outcome for the study would mean reduced number of days on the ventilator and lesser lung injury for the baby. Several neonatal units in the UK are already equipped with devices capable of delivering n-BiPAP. If shown to be effective, n-BiPAP can be readily integrated with day to day practice. With increased birth rate there is considerable demand on neonatal intensive care cots. Reduced number of ventilator days will allow for more efficient utilisation of resources. Families still need to travel long distances to specialist centres equipped with ventilators for preterm care. Early and successful extubation would mean that babies can move closer to home earlier.


Research activity codes: 6.7 PHYSICAL
Health categories: RESPIRATORY;REPRODUCTIVE HEALTH AND CHILDBIRTH