RESUMEN
Objective: To apply cumulative sum (CUSUM) to monitor a drug trial of nebulized hypertonic-saline in bronchiolitis. To test if monitoring with CUSUM control lines is practical and useful as a prompt to stop the drug trial early, if the study drug performs significantly worse than the comparator drug. Design: Prospective, open label, controlled trial using standard therapy (epinephrine) and study drug (hypertonic-saline) sequentially in two groups of patients. Setting: Hospital offering tertiary-level pediatric care. Patients: Children, 2 months to 2 years, with first episode of bronchiolitis, excluding those with cardiac disease, immunodeficiency and critical illness at presentation. Interventions: Nebulized epinephrine in first half of the bronchiolitis season (n = 35) and hypertonic saline subsequently (n = 29). Continuous monitoring of response to hypertonic-saline using CUSUM control-charts developed with epinephrineresponse data. Main outcome measures: Clinical score, tachycardia and total duration of hospital stay. Results: In the epinephrine group, the maximum CUSUM was +2.25 (SD 1.34) and minimum CUSUM was -2.26 (SD 1.34). CUSUM score with hypertonic-saline group stayed above the zero line throughout the study. There was no statistical difference in the post-treatment clinical score at 24 hours between the treatment groups {Mean (SD) 3.516 (2.816): 3.552 (2.686); 95% CI: -1.416 to + 1.356}, heart rate {Mean (SD) 136 (44): 137(12); 95% CI: -17.849 to +15.849) or duration of hospital stay (Mean (SD) 96.029 (111.41): 82.914 (65.940); 95% CI: -33.888 to +60.128}. Conclusions: The software we developed allows for drawing of control lines to monitor study drug performance. Hypertonicsaline performed as well or better than nebulized epinephrine in bronchiolitis.
RESUMEN
Parvovirus B19 is responsible for approximately 10% of all cases of nonimmune hydrops. An unusual case of perinatally acquired parvovirus infection in a neonate is reported who presented with nonimmune hydrops fetalis at D15 of life.