A randomised controlled trial of flow driver and bubble continuous positive airway pressure in preterm infants in a resource-limited setting.
OBJECTIVE
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.


METHODS
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.


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


METHODS
Neonates <37 weeks of gestation.


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


RESULTS
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.


BACKGROUND
ISRCTN22578364.
Scientific Research Centre of Maternal and Child Health, Yerev, Armenia.
P
P
Mazmanyan
BirthLink, London, UK.
K
K
Mellor
Medical Research Council Clinical Trials Unit at University College London, London, UK.
C J
CJ
Doré
Department of Medicine, Section of Neonatal Medicine, Chelsea & Westminster Campus, Imperial College London, London, UK.
N
N
Modi
D045422:Continuous Positive Airway Pressure / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D005260:Female; D006295:Health Resources; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D016015:Logistic Models; D008297:Male; D011203:Poverty; D011446:Prospective Studies; D011663:Pulmonary Surfactants; D012127:Respiratory Distress Syndrome, Newborn / Q000628:therapy*; D016896:Treatment Outcome
D011663:Pulmonary Surfactants
Infant newborn; Infant preterm; continuous positive airway pressure; low and middle income country; ventilation