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Double-blind, placebo-controlled pilot randomized trial of methylprednisolone infusion in pediatric acute respiratory distress syndrome.
Pediatr Crit Care Med. 2015 Mar; 16(3):e74-81.PC

Abstract

OBJECTIVE

Low-dose methylprednisolone therapy in adults with early acute respiratory distress syndrome reduces systemic inflammation, duration of mechanical ventilation, and ICU length of stay. We report a pilot randomized trial of glucocorticoid treatment in early pediatric acute respiratory distress syndrome.

DESIGN

Double-blind, placebo-controlled randomized clinical trial.

SETTING

Le Bonheur Children's Hospital, Memphis, TN.

PATIENTS

Children (0-18 yr) with acute respiratory distress syndrome undergoing mechanical ventilation.

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

This study demonstrates the feasibility of administering low-dose glucocorticoid therapy and measuring clinically relevant outcomes in pediatric acute respiratory distress syndrome. Changes in oxygenation and/or ventilation are consistent with early acute respiratory distress syndrome pathophysiology and results of similar clinical trials in adults. We propose and design a larger randomized trial to define the role of glucocorticoid therapy in pediatric acute respiratory distress syndrome.

Authors+Show Affiliations

1Prohealth Pediatrics, New York, NY. 2Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN. 3Pain Neurobiology Laboratory, University of Tennessee Health Science Center, Memphis, TN. 4Department of Clinical Pharmacy, Le Bonheur Children's Hospital & College of Pharmacy, University of Tennessee Health Science Center, Memphis, TN. 5Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, Memphis Veterans Affairs Medical Center, Memphis, TN.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25634565

Citation

Drago, Bonny B., et al. "Double-blind, Placebo-controlled Pilot Randomized Trial of Methylprednisolone Infusion in Pediatric Acute Respiratory Distress Syndrome." Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, vol. 16, no. 3, 2015, pp. e74-81.
Drago BB, Kimura D, Rovnaghi CR, et al. Double-blind, placebo-controlled pilot randomized trial of methylprednisolone infusion in pediatric acute respiratory distress syndrome. Pediatr Crit Care Med. 2015;16(3):e74-81.
Drago, B. B., Kimura, D., Rovnaghi, C. R., Schwingshackl, A., Rayburn, M., Meduri, G. U., & Anand, K. J. (2015). Double-blind, placebo-controlled pilot randomized trial of methylprednisolone infusion in pediatric acute respiratory distress syndrome. Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, 16(3), e74-81. https://doi.org/10.1097/PCC.0000000000000349
Drago BB, et al. Double-blind, Placebo-controlled Pilot Randomized Trial of Methylprednisolone Infusion in Pediatric Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2015;16(3):e74-81. PubMed PMID: 25634565.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind, placebo-controlled pilot randomized trial of methylprednisolone infusion in pediatric acute respiratory distress syndrome. AU - Drago,Bonny B, AU - Kimura,Dai, AU - Rovnaghi,Cynthia R, AU - Schwingshackl,Andreas, AU - Rayburn,Mark, AU - Meduri,G Umberto, AU - Anand,Kanwaljeet J S, PY - 2015/1/31/entrez PY - 2015/1/31/pubmed PY - 2015/12/15/medline SP - e74 EP - 81 JF - Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies JO - Pediatr Crit Care Med VL - 16 IS - 3 N2 - OBJECTIVE: Low-dose methylprednisolone therapy in adults with early acute respiratory distress syndrome reduces systemic inflammation, duration of mechanical ventilation, and ICU length of stay. We report a pilot randomized trial of glucocorticoid treatment in early pediatric acute respiratory distress syndrome. DESIGN: Double-blind, placebo-controlled randomized clinical trial. SETTING: Le Bonheur Children's Hospital, Memphis, TN. PATIENTS: Children (0-18 yr) with acute respiratory distress syndrome undergoing mechanical ventilation. 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: This study demonstrates the feasibility of administering low-dose glucocorticoid therapy and measuring clinically relevant outcomes in pediatric acute respiratory distress syndrome. Changes in oxygenation and/or ventilation are consistent with early acute respiratory distress syndrome pathophysiology and results of similar clinical trials in adults. We propose and design a larger randomized trial to define the role of glucocorticoid therapy in pediatric acute respiratory distress syndrome. SN - 1529-7535 UR - https://www.unboundmedicine.com/medline/citation/25634565/Double_blind_placebo_controlled_pilot_randomized_trial_of_methylprednisolone_infusion_in_pediatric_acute_respiratory_distress_syndrome_ L2 - https://doi.org/10.1097/PCC.0000000000000349 DB - PRIME DP - Unbound Medicine ER -