Abstract | OBJECTIVE: DESIGN: Double-blind, placebo-controlled randomized clinical trial. SETTING: Le Bonheur Children's Hospital, Memphis, TN. PATIENTS: INTERVENTIONS: Patients were randomly assigned to steroid or placebo groups within 72 hours of intubation. IV methylprednisolone administered as loading dose (2 mg/kg) and continuous infusions (1 mg/kg/d) on days 1-7 and then tapered over days 8-14. Both groups were ventilated according to the Acute Respiratory Distress Syndrome Network protocol modified for children. Daily surveillance was performed for adverse effects. MEASUREMENTS AND MAIN RESULTS: Thirty-five patients were randomized to the steroid (n = 17, no death) and placebo groups (n = 18, two deaths). No differences occurred in length of mechanical ventilation, ICU stay, hospital stay, or mortality between the two groups. At baseline, higher plateau pressures (p = 0.006) and lower Pediatric Logistic Organ Dysfunction scores (p = 0.04) occurred in the steroid group; other characteristics were similar. Despite higher plateau pressures on days 1 (p = 0.006) and 2 (p = 0.025) due to poorer lung compliance in the steroid group, they had lower PaCO2 values on days 2 (p = 0.009) and 3 (p = 0.014), higher pH values on day 2 (p = 0.018), and higher PaO2/FIO2 ratios on days 8 (p = 0.047) and 9 (p = 0.002) compared with the placebo group. Fewer patients in the steroid group required treatment for postextubation stridor (p = 0.04) or supplemental oxygen at ICU transfer (p = 0.012). Steroid therapy was not associated with detectable adverse effects. CONCLUSION:
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Authors | Bonny B Drago, Dai Kimura, Cynthia R Rovnaghi, Andreas Schwingshackl, Mark Rayburn, G Umberto Meduri, Kanwaljeet J S Anand |
Journal | Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
(Pediatr Crit Care Med)
Vol. 16
Issue 3
Pg. e74-81
(Mar 2015)
ISSN: 1529-7535 [Print] United States |
PMID | 25634565
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Glucocorticoids
- Oxygen
- Methylprednisolone
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Topics |
- Blood Gas Analysis
(statistics & numerical data)
- Child
- Child, Preschool
- Double-Blind Method
- Female
- Glucocorticoids
(therapeutic use)
- Hospital Mortality
- Humans
- Infant
- Infant, Newborn
- Infusions, Intravenous
- Intensive Care Units
(statistics & numerical data)
- Length of Stay
(statistics & numerical data)
- Male
- Methylprednisolone
(administration & dosage, adverse effects, therapeutic use)
- Oxygen
(administration & dosage, blood)
- Pilot Projects
- Respiration, Artificial
(mortality, statistics & numerical data)
- Respiratory Distress Syndrome
(blood, drug therapy, mortality, physiopathology)
- Treatment Outcome
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