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A randomised controlled trial of flow driver and bubble continuous positive airway pressure in preterm infants in a resource-limited setting
  1. P Mazmanyan1,
  2. K Mellor2,
  3. C J Doré3,
  4. N Modi4
  1. 1Scientific Research Centre of Maternal and Child Health, Yerev, Armenia
  2. 2BirthLink, London, UK
  3. 3Medical Research Council Clinical Trials Unit at University College London, London, UK
  4. 4Department of Medicine, Section of Neonatal Medicine, Chelsea & Westminster Campus, Imperial College London, London, UK
  1. Correspondence to Dr Pavel Mazmanyan, Scientific Research Centre of Maternal and Child Health Protection, Yerevan 0002, Armenia; pavelart{at}gmail.com

Abstract

Objectives The variable-flow flow driver (FD; EME) and continuous-flow bubble (Fisher-Paykel) continuous positive airway pressure (CPAP) systems are widely used. As these differ in cost and technical requirements, determining comparative efficacy is important particularly where resources are limited.

Design We performed a randomised, controlled, equivalence trial of CPAP systems. We specified the margin of equivalence as 2 days. We analysed binary variables by logistical regression adjusted for gestation, and log transformed continuous variables by multiple linear regression adjusted for gestation, sex and antenatal steroids.

Setting A neonatal unit with no blood gas analyser or surfactant availability and limited X-ray and laboratory facilities

Patients Neonates <37 weeks of gestation.

Interventions We provided CPAP at delivery followed by randomisation to FD or bubble (B).

Outcomes Primary outcome included total days receiving CPAP; secondary outcomes included days receiving CPAP, supplemental oxygen, ventilation, death, pneumothorax and nasal excoriation.

Results We randomised 125 infants (B 66, FD 59). Differences in infant outcomes on B and FD were not statistically significant. The median (range) for CPAP days for survivors was B 0.8 (0.04 to 17.5), FD 0.5 (0.04 to 5.3). B:FD (95% CI) ratios were CPAP days 1.3 (0.9 to 2.1), CPAP plus supplementary oxygen days 1.2 (0.7 to 1.9). B:FD (95% CI) ORs were death 2.3 (0.2 to 28), ventilation 2.1 (0.5 to 9), nasal excoriation 1.2 (0.2 to 8) and pneumothorax 2.4 (0.2 to 26).

Conclusions In a resource-limited setting we found B CPAP equivalent to FD CPAP in the total number of days receiving CPAP within a margin of 2 days.

Trial registration number ISRCTN22578364.

  • Infant preterm
  • Infant newborn
  • continuous positive airway pressure
  • ventilation
  • low and middle income country

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