Use of a modified bubble continuous positive airway pressure (bCPAP) device for children in respiratory distress in low- and middle-income countries: a safety study
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Date
2019
Authors
Bjorklund, Ashley R.
Odongkara Mpora, Beatrice
Steiner, Marie E.
Fischer, Gwenyth
Davey, Cynthia S.
Slusher, Tina M.
Journal Title
Journal ISSN
Volume Title
Publisher
Paediatrics and international child health
Abstract
While bubble continuous positive airway pressure (bCPAP) is commonly used in
low- and middle-income countries (LMIC) to support neonates with respiratory distress, there
are limited non-invasive support options for non-neonatal children.
Aim: To demonstrate safety of a new device designed to support children during respiratory
distress in LMIC.
Methods: A paediatric bCPAP device was designed called SEAL-bCPAP (Simplified Ear-plug
Adapted-bCPAP). SEAL-bCPAP is constructed from inexpensive, easily obtainable materials. The
nasal prong interface was modified from previously described neonatal bCPAP set-ups using
commercial ear-plug material to improve nasal seal. A prospective interventional study was
conducted to evaluate safety in children with respiratory distress treated with SEAL-bCPAP.
Patients aged 30 days to 5 years presenting to a hospital in northern Uganda from July 2015
to June 2016 were screened. Those with moderate–severe respiratory distress and/or hypoxia
despite nasal cannula oxygen were eligible for study. Enrolled patients were supported with
SEAL-bCPAP until respiratory improvement or death. Complications attributable to SEAL-bCPAP
were recorded. Clinical outcomes were compared with historical control pre-trial data.
Results: Eighty-three of 87 enrolled patients were included in the final analysis. No patients had
significant SEAL-bCPAP complications. Five patients had mild complications which resolved
(four with nasal irritation and one with abdominal distention). Trial patients had significant
(P < 0.0001) improvement in their TAL score, respiratory rate and O2sat after 2 h of SEAL-bCPAP.
Fifty-two of 64 patients (62.7%) with severe illness at Time1 did not have severe illness at Time2
(after 2 h of SEAL-bCPAP) (p < 0.0001). Unadjusted mortality rates were 12.2% (6/49) and 9.6%
(8/83), respectively, for pre-trial (historical control) and trial patients (p = 0.64); the study was not
powered to show efficacy.
Conclusions: The SEAL-bCPAP device is safe for treatment of respiratory distress in non-neonatal
children in LMIC. There is a trend toward decreased mortality that should be evaluated with
adequately powered clinical trials.
Description
Keywords
Bubble continuous positive airway pressure, Low- and middle-income countries, Global health, Respiratory support, International health, Child health, Device innovations
Citation
Ashley R. Bjorklund, Beatrice Odongkara Mpora, Marie E. Steiner, Gwenyth Fischer, Cynthia S. Davey & Tina M. Slusher (2019) Use of a modified bubble continuous positive airway pressure (bCPAP) device for children in respiratory distress in low- and middleincome countries: a safety study, Paediatrics and International Child Health, 39:3, 160-167, DOI: 10.1080/20469047.2018.1474698