Randomized Study of Early Continuous Positive Airways Pressure in Acute Respiratory Failure in Children With Impaired Immunity (SCARF) ISRCTN82853500

Objectives: Previous trials in adults with impaired immunity and respiratory failure suggest that early noninvasive ventilation avoids endotracheal intubation and improves survival. No randomized clinical trials have addressed this question in children. Design: We undertook an open, parallel-group randomized trial in three pediatric hospitals. Subjects: Children with impaired immunity and acute respiratory failure defined as tachypnoea (> 90th centile); a new requirement for supplemental oxygen; and new chest radiograph infiltrates. Interventions: Children were randomly assigned to early PICU admission for continuous positive airways pressure (early continuous positive airways pressure) or to standard care. The primary outcome was endotracheal intubation by 30 days. Measurements and Main Results: One-hundred fourteen children met inclusion criteria of whom 42 were randomized between January 2013 and January 2016. There was no significant difference in endotracheal intubation by 30 days with early continuous positive airways pressure (10/21; 48%) compared with standard care (5/21; 24%), odds ratio 2.9 (0.8–10.9), p value equals to 0.11. However, 30-day mortality was significantly higher with early continuous positive airways pressure (7/21; 33%) compared with standard care (1/21; 5%), odds ratio 10.0 (1.1–90.6), p value equals to 0.041. Mortality at 90 days was early continuous positive airways pressure (11/21; 52%) versus standard care (4/21; 19%), odds ratio 4.7 (1.2–18.6), p value equals to 0.029, whereas mortality at 1 year was similar early continuous positive airways pressure (13/21; 61.9%) versus standard care (9/21; 42.7%), odds ratio 2.2 (0.6–7.4), p value equals to 0.22. There were two serious adverse events: early continuous positive airways pressure (pneumothorax) and standard care (hemothorax). Conclusions: This study provided no evidence to support early PICU admission for continuous positive airways pressure in children with acute respiratory failure and impaired immunity. There was a trend toward increased endotracheal intubation and a higher early mortality in the early continuous positive airways pressure group. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (https://ift.tt/2gIrZ5Y). This study was funded by Great Ormond Street Hospital Children’s Charity (Registered Charity Number 235825) and supported by the National Institute for Health Research Great Ormond Street Hospital Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research, or the U.K. Department of Health. The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Dr. Peters and Ms. George received support for article research from the Great Ormond Street Hospital (GOSH) Children’s Charity. Registered Charity Number 235825. Dr. Peters disclosed that the study was supported by the National Institute for Health Research (NIHR) GOSH Biomedical Research Centre, and he received funding from Faron Pharmaceutics and Therakind. Dr. Agbeko’s institution received funding from Great Ormond Street Charity, Academic Health Science Network North East North Cumbria, and National Confidential Enquiry into Patient Outcome and Death; she received funding from the NIHR; and she received other support from Children’s Research Institute, Washington, DC. Dr. Davis received support for article research from GOSH Research funds for research nursing time to support study. Dr. Klein’s institution received funding from the NIHR, and he received support for article research from the NIHR. Ms. George’s institution received funding from Intensive Care National Audit & Research Centre on behalf of GOSH Children’s Charity. Dr. Veys received funding from Eusapharma and Novartis. Dr. Ray’s and Mr. Mouncey’s institutions received funding from the Department of Health’s NIHR Biomedical Research Centre’s funding scheme. Mr. Mouncey received support for article research from GOSH Children’s Charity. Drs. Harrison’s and Rowan’s institution received funding from GOSH Children’s Charity. The remaining authors have disclosed that they do not have any potential conflicts of interest. For information regarding this article, E-mail: mark.peters@ucl.ac.uk ©2018The Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

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