Alyssa H Silver1, Nora Esteban-Cruciani2, Gabriella Azzarone2, Lindsey C Douglas2, Diana S Lee2, Sheila Liewehr3, Joanne M Nazif2, Ilir Agalliu4, Susan Villegas5, Hai Jung H Rhim2, Michael L Rinke2, Katherine O'Connor2. 1. Division of Pediatric Hospital Medicine, Department of Pediatrics, alysilve@montefiore.org. 2. Division of Pediatric Hospital Medicine, Department of Pediatrics. 3. Division of Pediatric Hospital Medicine, Department of Pediatrics, Department of Pediatrics, Steven and Alexandra Cohen Children's Medical Center at North Shore-LIJ Health System, New Hyde Park, New York; and. 4. Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York; 5. Department of Pharmacy, Arnold and Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, New York Department of Pharmacy, The Children's Hospital at Montefiore, and.
Abstract
BACKGROUND AND OBJECTIVES: Bronchiolitis, the most common reason for hospitalization in children younger than 1 year in the United States, has no proven therapies effective beyond supportive care. We aimed to investigate the effect of nebulized 3% hypertonic saline (HS) compared with nebulized normal saline (NS) on length of stay (LOS) in infants hospitalized with bronchiolitis. METHODS: We conducted a prospective, randomized, double-blind, controlled trial in an urban tertiary care children's hospital in 227 infants younger than 12 months old admitted with a diagnosis of bronchiolitis (190completed the study); 113 infants were randomized to HS (93 completed the study), and 114 to NS (97 completed the study). Subjects received 4 mL nebulized 3% HS or 4 mL 0.9% NS every 4 hours from enrollment until hospital discharge. The primary outcome was median LOS. Secondary outcomes were total adverse events, subdivided as clinical worsening and readmissions. RESULTS: Patient characteristics were similar in groups. In intention-to-treat analysis, median LOS (interquartile range) of HS and NS groups was 2.1 (1.2-4.6) vs 2.1 days (1.2-3.8), respectively, P = .73. We confirmed findings with per-protocol analysis, HS and NS groups with 2.0 (1.3-3.3) and 2.0 days (1.2-3.0), respectively, P = .96. Seven-day readmission rate for HS and NS groups were 4.3% and 3.1%, respectively, P = .77. Clinical worsening events were similar between groups (9% vs 8%, P = .97). CONCLUSIONS: Among infants admitted to the hospital with bronchiolitis, treatment with nebulized 3% HS compared with NS had no difference in LOS or 7-day readmission rates.
RCT Entities:
BACKGROUND AND OBJECTIVES:Bronchiolitis, the most common reason for hospitalization in children younger than 1 year in the United States, has no proven therapies effective beyond supportive care. We aimed to investigate the effect of nebulized 3% hypertonic saline (HS) compared with nebulized normal saline (NS) on length of stay (LOS) in infants hospitalized with bronchiolitis. METHODS: We conducted a prospective, randomized, double-blind, controlled trial in an urban tertiary care children's hospital in 227 infants younger than 12 months old admitted with a diagnosis of bronchiolitis (190 completed the study); 113 infants were randomized to HS (93 completed the study), and 114 to NS (97 completed the study). Subjects received 4 mL nebulized 3% HS or 4 mL 0.9% NS every 4 hours from enrollment until hospital discharge. The primary outcome was median LOS. Secondary outcomes were total adverse events, subdivided as clinical worsening and readmissions. RESULTS:Patient characteristics were similar in groups. In intention-to-treat analysis, median LOS (interquartile range) of HS and NS groups was 2.1 (1.2-4.6) vs 2.1 days (1.2-3.8), respectively, P = .73. We confirmed findings with per-protocol analysis, HS and NS groups with 2.0 (1.3-3.3) and 2.0 days (1.2-3.0), respectively, P = .96. Seven-day readmission rate for HS and NS groups were 4.3% and 3.1%, respectively, P = .77. Clinical worsening events were similar between groups (9% vs 8%, P = .97). CONCLUSIONS: Among infants admitted to the hospital with bronchiolitis, treatment with nebulized 3% HS compared with NS had no difference in LOS or 7-day readmission rates.
Authors: David G Bundy; Troy E Richardson; Matthew Hall; Jean L Raphael; David C Brousseau; Staci D Arnold; Ram V Kalpatthi; Angela M Ellison; Suzette O Oyeku; Samir S Shah Journal: JAMA Pediatr Date: 2017-11-01 Impact factor: 16.193
Authors: Joshua Davis; Amy D Thompson; Jonathan M Mansbach; Pedro A Piedra; Kohei Kasagawa; Ashley F Sullivan; Janice A Espinola; Carlos A Camargo Journal: Hosp Pediatr Date: 2017-07-31