P Mazmanyan1, K Mellor2, C J Doré3, 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.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Entities:
Keywords:
Infant newborn; Infant preterm; continuous positive airway pressure; low and middle income country; ventilation
Authors: Elizabeth Wastnedge; Donald Waters; Sarah R Murray; Brian McGowan; Effie Chipeta; Alinane Linda Nyondo-Mipando; Luis Gadama; Gladys Gadama; Martha Masamba; Monica Malata; Frank Taulo; Queen Dube; Kondwani Kawaza; Patricia Munthali Khomani; Sonia Whyte; Mia Crampin; Bridget Freyne; Jane E Norman; Rebecca M Reynolds Journal: J Glob Health Date: 2021-12-30 Impact factor: 4.413