Abstract
BackgroundRespiratory 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.MethodsWe 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 extubation2. Oxygen requirement at 28 days of age and at 36 weeks' corrected gestational age3. Total days on ventilator, n-CPAP/n-BiPAP4. Number of ventilator days following first extubation attempt5. pH and partial pressure of carbon dioxide in the first post extubation blood gas6. Duration of hospital stay7. Rate of abdominal distension requiring cessation of feeds8. Rate of apnoea and bradycardia9. The age at transfer back to referral centre in daysThe 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 numberISRCTN: ISRCTN18921778
Highlights
Respiratory distress syndrome remains a significant problem among premature infants
Mechanical ventilation through an endotracheal tube is associated with ventilator associated lung injury which may be a significant factor in the development of chronic lung disease of prematurity (Bronchopulmonary dysplasia) - a condition associated with significant morbidity and mortality among preterm infants
In this study we aim to determine if the use of nasal biphasic positive airway pressure (n-BiPAP) is more effective than single level variable flow nasal continuous positive airway pressure (n-CPAP) in preventing extubation failure in babies born before 30 weeks’ gestation and less than 2 weeks old
Summary
Aims The primary aim of this study is to compare the risk of extubation failures for 48 hours after the first extubation comparing the use of n-BiPAP or n-CPAP in infants born before 30 weeks’ gestation and less than two weeks old. Serious adverse event (SAE) Any adverse event that a) Results in death b) Is life-threatening c) Requires hospitalisation or prolongation of existing hospitalisation d) Results in persistent or significant disability or incapacity Expected serious adverse events Due to the high risk population of extremely premature infants with gestational age under 30 weeks, the following are serious adverse events which could be expected for this population during the course of the study: (1) Intraventricular haemorrhage defined as haemorrhage causing ventricular dilatation with or without brain parenchymal involvement (2) Periventricular leukomalacia on cranial ultrasound scan imaging (3) Necrotising enterocolitis requiring surgery (4) Patent ductus arteriosus requiring treatment (5) Retinopathy of prematurity requiring laser treatment (6) Pneumothorax within 7 days after extubation (7) Evidence of traumatic nasal injury (8) Death. List of abbreviations used n-CPAP: Nasal Continuous Positive Airway Pressure; n-BiPAP: Nasal biphasic positive airway pressure; NIPPV: Non Invasive Positive Pressure Ventilation; DMC: Data Monitoring Committee; TSC: Trial Steering Committee; TMG: Trial Management Committee; RPG: Research Parent Group; AE: Adverse Event; SAE: Serious Adverse Event
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