Background: 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.
Bibliographical noteFunding Information:
Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
This work was supported by the Thrasher Research Fund (Salt Lake City, UT); University of Minnesota; Pediatric Device Innovation Consortium (PDIC); Office of Discovery and Translation (ODAT) (Minneapolis, MN) and Masonic Children?s Hospital (Minneapolis, MN). We should like to thank our dedicated BUBBLES team study coordinator, Gloria Omoko Amongi, and study nurses Tonny Okino, Judith Aceng, Florence Amito, Geoffrey Okello and Babra Adong; also the administration and all the physicians/medical officers, nurses and support staff at Gulu Regional Referral Hospital, Gulu, Uganda without whom this study would not have been possible. We are grateful to the following who donated supplies: suction machines by Glen Kosirog (Kosirog Rexall Pharmacy and Homeware, Chicago, IL); pulse oximeters by Andrew Larson (Biomedical Engineering, Hennepin County Medical Center, Minneapolis, MN); and nasogastric tubes, nasal cannulas, gloves by Global Health Ministries (Minneapolis, MN). Finally, we should like to thank Joseph Hale, engineering consultant, University of Minnesota Medical Device Center, for assistance in device design, Abigail Faulman for assistance in nurse training and Hellen Aanyu-Tukamuhebwa, pulmonary consultant, Mulago Hospital and Makerere University, Kampala, Uganda.
This work was supported by the Thrasher Research Fund (Salt Lake City, UT); University of Minnesota; Pediatric Device Innovation Consortium (PDIC); Office of Discovery and Translation (ODAT) (Minneapolis, MN) and Masonic Children’s Hospital (Minneapolis, MN).
- ACU, acute care unit
- BUBBLES, bCPAP used beyond babies in low economic settings
- Bubble continuous positive airway pressure
- CPAP, continuous positive airway pressure
- LMIC, low- and middle-income countries
- OR, odds ratio
- Osat, oxygen saturation
- RR, respiratory rate
- SD, standard deviation
- SEAL-bCPAP, simplified ear-plug adapted low-cost bCPAP
- TAL score, modified TAL clinical score
- bCPAP, bubble continuous positive airway pressure
- child health
- cmHO, cm of water
- device innovations
- global health
- international health
- low- and middle-income countries
- respiratory support