Ideal Steroids for Asthma Treatment in the PICU

NCT ID: NCT03900624

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-21
• Study Completion Date: 2022-05-15

Brief Summary

Determine if differences in (1) pediatric intensive care unit length of stay, (2) continuous nebulized albuterol duration, and (3) a composite outcome of advanced asthma therapy incidence including use of non-invasive ventilation (NIV), terbutaline, inhaled helium and mechanical ventilation between cohorts of children admitted with status asthmaticus to the PICU treated with either IV dexamethasone (DM) or methylprednisolone (MP).

Detailed Description

As the pathophysiology of an acute asthma exacerbation is dysregulated inflammatory pathways, standard treatment includes the prompt initiation of intravenous systemic corticosteroids. Corticosteroids reduce the production of many mediators involved in the inflammatory process and inhibit macrophages, monocytes, T-lymphocytes, eosinophils, and basophils, which are activated during this process. Furthermore, corticosteroids improve the efficacy of beta-2 agonists, such as albuterol, a nebulized medication used for bronchodilation in acute asthma exacerbations. There remains an ongoing dialogue among the expert medical community regarding the superiority of specific IV corticosteroid, dosing, route and delivery. This debate continues secondary to a lack of definitive comparative data in the literature. While the benefits of receiving systemic corticosteroids has been demonstrated in multiple studies, to date, no head-to-head trials have been conducted comparing IV systemic corticosteroids in the PICU setting (DM vs. MP).

While several systemic corticosteroids are FDA approved for the treatment of asthma exacerbation including prednisone, prednisolone, MP and DM, the standard practice in PICU-level care is IV MP every 6 hours until enteral medications can be safely tolerated. Recent data from emergency room literature would suggest there is equipoise in use of dexamethasone as an alternative for methylprednisolone due to its increased glucocorticoid (anti-inflammatory) potency. Steroid agents are chosen at the discretion of clinical providers based upon a child's capacity to tolerate enteral medications and the specific clinical setting (outpatient vs. general inpatient vs. critical inpatient).

The investigators have performed a retrospective study over a 2-year period to assess if differences in clinical outcomes or adverse events exist in cohorts defined by DM exposure in the ER. Their data revealed no differences, but most children were switched to MP during their PICU stay making data analyses severely confounded by exposure to the defining characteristics of the comparative cohort. The investigators seek to first prospectively consent individuals to receive DM during their PICU asthma treatment and compare outcomes to PICU asthmatics concurrently admitted to the PICU receiving local standard care (MP). Johns Hopkins All Children's Hospital (JHACH) admits approximately 150 asthmatics per year in the PICU and the investigators hope to enroll up to 50 subjects into a DM only arm. The comparative standard care arm will be assessed at the end of the study period. Primary outcomes include (1) PICU Length of Stay, (2) Continuous nebulized albuterol duration, and (3) a composite outcome including use of non-invasive ventilation (NIV), terbutaline, inhaled helium, inhaled anesthetic gas, mechanical ventilation, and extracorporeal life support. This research will provide the needed epidemiologic and basic comparative data required to power and conduct a definitive, head-to-head trial of DM vs. MP.

Conditions

Asthma Childhood

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylprednisolone Arm

Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Dexamethasone Arm

Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus

Interventions

Dexamethasone

Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• children with existing tracheostomy, cystic fibrosis, and pulmonary hypertension

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins All Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony A Sochet, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins All Children's Hospital

Locations

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 9728226 (View on PubMed)

Svedmyr N. Action of corticosteroids on beta-adrenergic receptors. Clinical aspects. Am Rev Respir Dis. 1990 Feb;141(2 Pt 2):S31-8.

Reference Type: BACKGROUND

PMID: 1968733 (View on PubMed)

Scarfone RJ, Fuchs SM, Nager AL, Shane SA. Controlled trial of oral prednisone in the emergency department treatment of children with acute asthma. Pediatrics. 1993 Oct;92(4):513-8.

Reference Type: BACKGROUND

PMID: 8414819 (View on PubMed)

Connett GJ, Warde C, Wooler E, Lenney W. Prednisolone and salbutamol in the hospital treatment of acute asthma. Arch Dis Child. 1994 Mar;70(3):170-3. doi: 10.1136/adc.70.3.170.

Reference Type: BACKGROUND

PMID: 8135557 (View on PubMed)

Storr J, Barrell E, Barry W, Lenney W, Hatcher G. Effect of a single oral dose of prednisolone in acute childhood asthma. Lancet. 1987 Apr 18;1(8538):879-82. doi: 10.1016/s0140-6736(87)92857-1.

Reference Type: BACKGROUND

PMID: 2882288 (View on PubMed)

Gleeson JG, Loftus BG, Price JF. Placebo controlled trial of systemic corticosteroids in acute childhood asthma. Acta Paediatr Scand. 1990 Nov;79(11):1052-8. doi: 10.1111/j.1651-2227.1990.tb11382.x.

Reference Type: BACKGROUND

PMID: 2267922 (View on PubMed)

Kattan M, Gurwitz D, Levison H. Corticosteroids in status asthmaticus. J Pediatr. 1980 Mar;96(3 Pt 2):596-9. doi: 10.1016/s0022-3476(80)80872-9.

Reference Type: BACKGROUND

PMID: 7359263 (View on PubMed)

Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10.

Reference Type: BACKGROUND

PMID: 24515516 (View on PubMed)

Paniagua N, Lopez R, Munoz N, Tames M, Mojica E, Arana-Arri E, Mintegi S, Benito J. Randomized Trial of Dexamethasone Versus Prednisone for Children with Acute Asthma Exacerbations. J Pediatr. 2017 Dec;191:190-196.e1. doi: 10.1016/j.jpeds.2017.08.030.

Reference Type: BACKGROUND

PMID: 29173304 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00187813

Identifier Type: -

Identifier Source: org_study_id