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

Trials

Extubate Trial Group¹  Suresh Victor¹ 

[1] Ward 68, 2nd Floor, St Mary's Hospital for Women and Children, Manchester, UK M13 9WL

关键词: Continuous Positive Airway Pressure;    Biphasic Continuous Positive Airway Pressure;    Neonatal Intensive Care;    Randomized;    Clinical trials;    Humans;    Newborn;    Preterm birth Infant;   

Others  :  1095750
DOI  :  10.1186/1745-6215-12-257

 received in 2011-10-07, accepted in 2011-12-09,  发布年份 2011

【 摘 要 】

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

【 授权许可】

   
2011 Victor and Extubate Trial Group; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Davis PG, Henderson-Smart DJ: Nasal continuous positive airways pressure immediately after extubation for preventing morbidity in preterm infants. Cochrane Database of Systematic Reviews 2003.
• [2]Thomson MA, Yoder BA, Winter VT, Martin H, Catland D, Siler-Khodr TM, Coalson JJ: Treatment of immature baboons for 28 days with early nasal continuous positive airway pressure. Am J Respir Crit Care Med 2004, 169:1054-1062.
• [3]Booth C, Premkumar MH, Yannoulis A, Thomson M, Harrison M, Edwards AD: Sustainable use of continuous positive airway pressure in extremely preterm infants during the first week after delivery. Arch Dis Child Fetal Neonatal Ed 2006, 91:F398-F402.
• [4]Davis PG, Lemyre B, Paoli AG: Nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) for preterm neonates after extubation. Cochrane Database of Systematic Reviews 2001.
• [5]Aghai ZH, Saslow JG, Nakhla T, Amendolia B, Longo D, Kemble N, Kaki S, Sutsko R, Saslow JG, Stahl GE: Synchronized nasal intermittent positive pressure ventilation (SNIPPV) decreases work of breathing (WOB) in premature infants with respiratory distress syndrome (RDS) compared to nasal continuous positive airway pressure (NCPAP). Pediatr Pulmonol 2006, 41:875-881.
• [6]Migliori C, Motta M, Angeli A, Chirico G: Nasal bilevel vs. continuous positive airway pressure in preterm infants. Pediatr Pulmonol 2005, 40:426-430.
• [7]Lista G, Casoldi F, Fontana P, Daniele I, Cavigioli F, Rossi S, Manusco D, Reali R: Nasal CPAP versus bi-level nasal CPAP in preterm babies with respiratory distress syndrome: a randomised control trial. Archives of Disease in Childhood Fetal and Neonatal Edition 2010, 95(2):F85-F89.
• [8]Moa G, Nilsson K, Zetterstrom H, Jonsson LO: A new device for administration of nasal continuous positive airway pressure in the newborn: an experimental study. Crit Care Med 1988, 16:1238-1242.
• [9]Courtney SE, Pyon KH, Saslow JG, Pandit PB, Habib RH: Lung recruitment and breathing pattern during variable versus continuous flow nasal continuous positive airway pressure in premature infants: an evaluation of three devices. Pediatrics 2001, 107:304-308.
• [10]Pandit PB, Courtney SE, Pyon KH, Saslow JG, Habib RH: Work of breathing during constant- and variable-flow nasal continuous positive airway pressure in preterm neonates. Pediatrics 2001, 108:682-685.