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Original article
A randomised controlled trial of flow driver and bubble continuous positive airway pressure in preterm infants in a resource-limited setting P Mazmanyan,1 K Mellor,2 C J Doré,3 N Modi4 1
Scientific Research Centre of Maternal and Child Health, Yerev, Armenia 2 BirthLink, London, UK 3 Medical Research Council Clinical Trials Unit at University College London, London, UK 4 Department of Medicine, Section of Neonatal Medicine, Chelsea & Westminster Campus, Imperial College London, London, UK Correspondence to Dr Pavel Mazmanyan, Scientific Research Centre of Maternal and Child Health Protection, Yerevan 0002, Armenia;
[email protected] Received 22 February 2015 Revised 3 July 2015 Accepted 13 July 2015 Published Online First 13 August 2015
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 30 years ago, CPAP devices have proliferated and currently there are a large number of delivery systems. Two devices widely used for the administration of continuous CPAP are the flow driver (FD) and
What is already known on this topic ▸ Bubble continuous positive airway pressure (CPAP) is a relatively simple health technology that can be delivered safely in low-income and middle-income countries. ▸ The majority of studies of CPAP in low-income and middle-income countries are case-series describing implementation, safety and cost-effectiveness.
What this study adds ▸ This study adds to the small number of randomised controlled trials of CPAP in low-income and middle-income countries. ▸ Bubble is equivalent to flow driver within a margin of 2 CPAP days; safety benefits from flow driver CPAP cannot be excluded. ▸ It is possible to conduct a randomised evaluation of an important neonatal intervention without specific funding in a resource-limited setting.
bubble systems. The FD is in established use in the developed world and there has been renewed interest in bubble CPAP systems. The systems differ substantially in cost with bubble CPAP considerably cheaper. Bubble CPAP is simple in concept and involves expiration against a pressure generated by bubbling gas under water. The airway distending pressure is a function of the depth of the expiratory tubing under water. A basic CPAP circuit requires a gas flow source and humidification, nasal prongs, tubing and a water container. In order to be adopted as a standard of care it is necessary to demonstrate that bubble CPAP and FD CPAP have equivalent efficacy. The demonstration of equivalent efficacy would be an important step towards improving healthcare and outcomes for vulnerable infants worldwide and of particular benefit in low-income and middle-income settings.
METHODS We conducted a single centre, prospective, randomised controlled equivalence trial at the Neonatal Unit of the Research Center Maternal and Child Health Protection, Yerevan, Armenia. The neonatal
Mazmanyan P, et al. Arch Dis Child Fetal Neonatal Ed 2016;101:F16–F20. doi:10.1136/archdischild-2015-308464
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Original article unit admits approximately 140 preterm babies and ventilates around 35 infants each year. Surfactant is unavailable; at the time of the trial the neonatal unit had no access to blood gas analyser and limited X-ray and laboratory facilities. All infants born
