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Corticosteroid

Dexamethasone Administration for Bronchiolitis (BroncHI Trial)

Phase < 1
Waitlist Available
Research Sponsored by IDeA States Pediatric Clinical Trials Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intervention: 72 hours; follow-up: 30 days
Awards & highlights

Summary

This trial aims to see if dexamethasone can be effectively given to infants with bronchiolitis. The medication helps reduce inflammation in their airways, making it easier for them to breathe. The study focuses on infants with certain health histories. Dexamethasone has been studied in various trials for its effectiveness in treating respiratory conditions in infants, including bronchiolitis and bronchopulmonary dysplasia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intervention: 72 hours; follow-up: 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and intervention: 72 hours; follow-up: 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants that receive 2 doses of dexamethasone per protocol.

Side effects data

From 2015 Phase 2 trial • 36 Patients • NCT02011113
72%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
NASOPHARYNGITIS
25%
PYREXIA
25%
CONSTIPATION
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
PNEUMONIA
14%
DYSGEUSIA
11%
FATIGUE
11%
EPISTAXIS
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
8%
RASH MACULO-PAPULAR
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
CANCER PAIN
6%
DECUBITUS ULCER
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
CYSTITIS
6%
DIABETES MELLITUS
6%
GASTROENTERITIS
6%
RESTLESSNESS
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
WEIGHT INCREASED
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
SEPSIS
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dexamethasone AdministrationExperimental Treatment1 Intervention
Dexamethasone will be given orally to all consented participants. Two doses will be administered within 12-48 hours, with at least the 1st dose administered during the bronchiolitis hospitalization. If the participant is discharged before the 2nd dose, it will be administered at home.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone Oral
2020
N/A
~14110

Find a Location

Who is running the clinical trial?

IDeA States Pediatric Clinical Trials NetworkLead Sponsor
5 Previous Clinical Trials
1,191 Total Patients Enrolled
1 Trials studying Bronchiolitis
228 Patients Enrolled for Bronchiolitis
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,950 Total Patients Enrolled
3 Trials studying Bronchiolitis
1,306 Patients Enrolled for Bronchiolitis
University of NebraskaOTHER
544 Previous Clinical Trials
1,144,988 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05994183 — Phase < 1
Bronchiolitis Research Study Groups: Dexamethasone Administration
Bronchiolitis Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT05994183 — Phase < 1
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05994183 — Phase < 1
~0 spots leftby Mar 2025
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