Trial Outcomes & Findings for Ideal Steroids for Asthma Treatment in the PICU (NCT NCT03900624)
NCT ID: NCT03900624
Last Updated: 2024-02-23
Results Overview
Hospital length of stay measured in days.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
From enrollment through hospital discharge, up to 1 week
Results posted on
2024-02-23
Participant Flow
Participant milestones
| Measure |
Methylprednisolone Arm - Standard Care
Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone 0.5mg/kg/dose every 6-hours for 5-days.
|
Dexamethasone Arm - Interventional Arm
Non-randomized, open-label, prospective use of intravenous dexamethasone 0.25 mg/kg/dose every 6 hours for 2-days for children admitted to the PICU with status asthmaticus.
Dexamethasone: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
31
|
|
Overall Study
COMPLETED
|
61
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Methylprednisolone Arm - Standard Care
n=61 Participants
Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.
|
Dexamethasone Arm - Interventional Arm
n=31 Participants
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus.
Dexamethasone: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.7 years
STANDARD_DEVIATION 3.8 • n=61 Participants
|
9.3 years
STANDARD_DEVIATION 3.5 • n=31 Participants
|
9.6 years
STANDARD_DEVIATION 3.8 • n=92 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=61 Participants
|
13 Participants
n=31 Participants
|
43 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=61 Participants
|
18 Participants
n=31 Participants
|
49 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
NHLBI Asthma Classification
Intermittent
|
10 Participants
n=61 Participants
|
4 Participants
n=31 Participants
|
14 Participants
n=92 Participants
|
|
NHLBI Asthma Classification
Mild Persistent
|
13 Participants
n=61 Participants
|
7 Participants
n=31 Participants
|
20 Participants
n=92 Participants
|
|
NHLBI Asthma Classification
Moderate Persistent
|
26 Participants
n=61 Participants
|
10 Participants
n=31 Participants
|
36 Participants
n=92 Participants
|
|
NHLBI Asthma Classification
Severe Persistent
|
12 Participants
n=61 Participants
|
10 Participants
n=31 Participants
|
22 Participants
n=92 Participants
|
|
Pediatric Asthma Severity Score
|
11 units on a scale
n=61 Participants
|
10.5 units on a scale
n=31 Participants
|
11 units on a scale
n=92 Participants
|
PRIMARY outcome
Timeframe: From enrollment through hospital discharge, up to 1 weekHospital length of stay measured in days.
Outcome measures
| Measure |
Methylprednisolone Arm - Standard Care
n=61 Participants
Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.
|
Dexamethasone Arm - Interventional Arm
n=31 Participants
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus.
Dexamethasone: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
|
|---|---|---|
|
Length of Stay
|
2.9 days
Interval 2.1 to 4.0
|
2.9 days
Interval 1.8 to 4.1
|
SECONDARY outcome
Timeframe: From enrollment through hospital discharge, up to 1 weekDuration (in days) of continuous nebulized albuterol.
Outcome measures
| Measure |
Methylprednisolone Arm - Standard Care
n=61 Participants
Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.
|
Dexamethasone Arm - Interventional Arm
n=31 Participants
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus.
Dexamethasone: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
|
|---|---|---|
|
Duration of Continuous Nebulized Albuterol
|
1 days
Interval 0.5 to 1.9
|
0.8 days
Interval 0.5 to 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment through hospital discharge, up to 1 weekNumber of participants receiving an adjunctive therapy: * use of non-invasive ventilation (NIV) * terbutaline * inhaled helium * inhaled anesthetic gas * mechanical ventilation * extracorporeal life support
Outcome measures
| Measure |
Methylprednisolone Arm - Standard Care
n=61 Participants
Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.
|
Dexamethasone Arm - Interventional Arm
n=31 Participants
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus.
Dexamethasone: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
|
|---|---|---|
|
Number of Participants Receiving an Adjunctive Asthma Therapy
|
41 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment through hospital discharge, up to 1 weekRates 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.
Outcome measures
| Measure |
Methylprednisolone Arm - Standard Care
n=61 Participants
Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.
|
Dexamethasone Arm - Interventional Arm
n=31 Participants
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus.
Dexamethasone: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
|
|---|---|---|
|
Corticosteroid-related Adverse Events
Hyperglycemia
|
7 Participants
|
2 Participants
|
|
Corticosteroid-related Adverse Events
Hypertension
|
1 Participants
|
1 Participants
|
|
Corticosteroid-related Adverse Events
Adrenal insufficiency
|
2 Participants
|
0 Participants
|
|
Corticosteroid-related Adverse Events
Altered mentation
|
2 Participants
|
0 Participants
|
|
Corticosteroid-related Adverse Events
Clinically-relevant gastrointestinal bleeding
|
0 Participants
|
0 Participants
|
|
Corticosteroid-related Adverse Events
Gastritis
|
0 Participants
|
0 Participants
|
|
Corticosteroid-related Adverse Events
Necrotizing enterocolitis
|
0 Participants
|
0 Participants
|
|
Corticosteroid-related Adverse Events
Ventilator associated pneumonia
|
0 Participants
|
0 Participants
|
Adverse Events
Methylprednisolone Arm - Standard Care
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Dexamethasone Arm - Interventional Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methylprednisolone Arm - Standard Care
n=61 participants at risk
Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.
|
Dexamethasone Arm - Interventional Arm
n=31 participants at risk
Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus.
Dexamethasone: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia
|
11.5%
7/61 • Number of events 7 • From enrollment to hospital discharge or 30-days; whichever comes first.
|
6.5%
2/31 • Number of events 2 • From enrollment to hospital discharge or 30-days; whichever comes first.
|
|
General disorders
Hypertension
|
1.6%
1/61 • Number of events 1 • From enrollment to hospital discharge or 30-days; whichever comes first.
|
3.2%
1/31 • Number of events 1 • From enrollment to hospital discharge or 30-days; whichever comes first.
|
|
Endocrine disorders
Adrenal Insufficiency
|
3.3%
2/61 • Number of events 2 • From enrollment to hospital discharge or 30-days; whichever comes first.
|
0.00%
0/31 • From enrollment to hospital discharge or 30-days; whichever comes first.
|
|
Nervous system disorders
Altered Mentation
|
3.3%
2/61 • Number of events 2 • From enrollment to hospital discharge or 30-days; whichever comes first.
|
0.00%
0/31 • From enrollment to hospital discharge or 30-days; whichever comes first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place