NCT03900624 (iSTAT PICU) is a Phase 4 clinical trial of Dexamethasone in Asthma Childhood, sponsored by Johns Hopkins All Children's Hospital.

Who is sponsoring NCT03900624?

NCT03900624 is sponsored by Johns Hopkins All Children's Hospital.

What drugs are being tested in NCT03900624?

Interventions in NCT03900624: Dexamethasone.

What condition does NCT03900624 study?

NCT03900624 studies Asthma Childhood.

Is NCT03900624 still recruiting?

NCT03900624 is currently completed. Last updated 23 February 2024.

Are results published for NCT03900624?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-23 · How we verify

NCT03900624: iSTAT PICU

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ideal Steroids for Asthma Treatment in the PICU

Completed Phase 4 Results posted Last updated 23 February 2024

What this trial tests

Phase 4 trial testing Dexamethasone in Asthma Childhood in 92 participants. Completed in 15 May 2022.

Timeline

21 April 2019

Primary endpoint
31 December 2021

15 May 2022

Quick facts

Lead sponsor	Johns Hopkins All Children's Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	92
Start date	21 April 2019
Primary completion	31 December 2021
Estimated completion	15 May 2022
Sites	1 location across United States

Drugs / interventions tested

Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

Asthma Childhood — all drugs for Asthma Childhood →

Sponsor

Johns Hopkins All Children's Hospital

Who can join

Adults 5 to 17, any sex, with Asthma Childhood. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Length of Stay Primary · From enrollment through hospital discharge, up to 1 week

Hospital length of stay measured in days.

Group	Value	95% CI
Methylprednisolone Arm - Standard Care	2.9	2.1 – 4
Dexamethasone Arm - Interventional Arm	2.9	1.8 – 4.1

Duration of Continuous Nebulized Albuterol Secondary · From enrollment through hospital discharge, up to 1 week

Duration (in days) of continuous nebulized albuterol.

Group	Value	95% CI
Methylprednisolone Arm - Standard Care	1	0.5 – 1.9
Dexamethasone Arm - Interventional Arm	0.8	0.5 – 1.7

Number of Participants Receiving an Adjunctive Asthma Therapy Secondary · From enrollment through hospital discharge, up to 1 week

Number of participants receiving an adjunctive therapy: * use of non-invasive ventilation (NIV) * terbutaline * inhaled helium * inhaled anesthetic gas * mechanical ventilation * extracorporeal life support

Group	Value	95% CI
Methylprednisolone Arm - Standard Care	41
Dexamethasone Arm - Interventional Arm	16

Corticosteroid-related Adverse Events Secondary · From enrollment through hospital discharge, up to 1 week

Rates of known corticosteroid-related adverse events including clinically-relevant gastrointestinal bleeding, gastritis, ventilator associated pneumonia, necrotizing enterocolitis, hypertension, hyperglycemia, altered mentation (including hallucinations and delirium), and adrenal insufficiency observed prior to hospital discharge.

Hyperglycemia

Group	Value	95% CI
Methylprednisolone Arm	7
Dexamethasone Arm	2

Hypertension

Group	Value	95% CI
Methylprednisolone Arm	1
Dexamethasone Arm	1

Adrenal insufficiency

Group	Value	95% CI
Methylprednisolone Arm	2
Dexamethasone Arm	0

Altered mentation

Group	Value	95% CI
Methylprednisolone Arm	2
Dexamethasone Arm	0

Clinically-relevant gastrointestinal bleeding

Group	Value	95% CI
Methylprednisolone Arm	0
Dexamethasone Arm	0

Gastritis

Group	Value	95% CI
Methylprednisolone Arm	0
Dexamethasone Arm	0

Necrotizing enterocolitis

Group	Value	95% CI
Methylprednisolone Arm	0
Dexamethasone Arm	0

Ventilator associated pneumonia

Group	Value	95% CI
Methylprednisolone Arm	0
Dexamethasone Arm	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment to hospital discharge or 30-days; whichever comes first.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Methylprednisolone Arm - Standard Care

Serious: 0/61 (0%)

Deaths: 0/61

Dexamethasone Arm - Interventional Arm

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (4 terms — click to expand)

Reaction	System	Methylprednisolone Arm - S…	Dexamethasone Arm - Interv…
Hyperglycemia	Endocrine disorders	—	—
Adrenal Insufficiency	Endocrine disorders	—	—
Altered Mentation	Nervous system disorders	—	—
Hypertension	General disorders	—	—

Data from ClinicalTrials.gov NCT03900624 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Dexamethasone

Trials testing the same drug.

NCT07543458 — Therapeutics for Moderate and Severe Dengue · Phase 3 · not yet recruiting
NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological · Phase 1, PHASE2 · not yet recruiting
NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Asthma Childhood

Currently open trials in the same condition.

NCT07129616 — Remote Monitoring of Asthma in Children and Young People · recruiting
NCT07412769 — ASMact: Study on Management of Bronchial Asthma · recruiting

Other Johns Hopkins All Children's Hospital trials

Trials by the same sponsor.

NCT06628778 — Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids · Phase 3 · not yet recruiting
NCT07455396 — Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Ped · Phase 2 · not yet recruiting
NCT06223828 — Azithromycin for Critical Asthma - Pediatrics · Phase 2, PHASE3 · recruiting
NCT06346782 — Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy (I-PCIT) in Pediatric Cancer · NA · recruiting
NCT05470517 — Antibiotic Instillation in Appendicitis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03900624 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins All Children's Hospital
Last refreshed: 23 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03900624.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing