NCT07858773Not yet recruitingPhase 4
Prevent Wheeze Trial
Single Dose Dexamethasone for the Prevention of Recurrent Wheeze in at Risk Children With First Episode LRTI: a Multi-country RCT in Two Low- and Middle-income Countries.
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
This trial investigates whether a single dose of dexamethasone will prevent recurrent wheezing in children at high-risk for asthma admitted to hospital with a lower respiratory tract infection (LRTI). Eligible children will be identified and enrolled upon hospital admission or during hospitalisation and allocated to receive either dexamethasone 0.6 mg/kilogram body weight or the similar number of placebo tablets (allocation ratio 1:1). The follow-up is 12 months and comprises scheduled on-site examinations by physician and study nurse, scheduled phone contacts, and registrations of new LRTI-episodes (if any). Nasopharyngeal swabs and blood will be collected at specified visits. The children will be invited to a follow-up study at school age for lung function assessments.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 486 (estimated)
- First submitted
- 24 Sept 2026
- Start date
- 1 Feb 2027
- Primary completion date
- 30 Jan 2029
- Lead sponsor
- Norwegian University of Science and Technology
- Diseases
- Asthma
- NCT number
- NCT07858773
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 486
- From 1 Feb 2027 to the primary completion date, 30 Jan 2029
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic corticosteroid treatment the previous 6 months
- Inhaled corticosteroid treatment, at any time, for \>2 weeks
- Clinical suspicion of bacterial pneumonia based upon a temperature ≥39.0°C and at least one of the following: 1. Unilaterally decreased breath sounds or unilateral percussion dullness 2. Pulmonary lobar consolidation and/or radiological high suspicion of empyema on chest x-ray if this is obtained prior to inclusion in the trial. Fills other criteria for high likelihood of bacterial pneumonia (on clinicians' evaluation or CRP\>40)
- Severe wheeze defined by TAL score\* \>=11 or need for intensive care unit treatment with invasive ventilation at screening.
- Previous admission for a LRTI or physician verified LRTI
Other illness
- Chronic illness other than atopy (eczema, food allergy),
- Evidence of any bacterial infection other than bacterial LRTI, including, but not exclusively: 1. Clinical septicemia 2. Urinary tract infection 3. Meningitis
- varicella infection or contact during the last 2-3 weeks
- Fulfill criteria for ICS at time of inclusion, at treating physicians discretion, guided by annex on criteria for unblinding due to medical condition needing open CS treatment (criteria for unbinding Criteria for unblinding.docx)
Other
- participation in another trial
Who the study is looking for
- Age 3-24 months
- LRTI (WHO definition LRTI: Cough or difficulties breathing
- \+ plus either fast breathing ( 2-12 months: \> 50 breaths/minute 13-24 months: \>40/minute) or: lower chest wall indrawing (retractions/nasal flare/difficulties breathing/wheeze) Acute:\<7 days duration of LRTI symptoms
- No history of previous LRTI/wheeze
- \+ 1 or more risk factors for recurrent wheeze:
- Clinical wheeze by presentation (indicated in TAL score\>=1 for wheeze item). The scoring matrix is here and in the annex.
- Indoor pollution exposure: Tobacco smoke exposure a) during pregnancy or b) in house where child lives (regular \>= 2week) or polluting cooking facility
- Atopic/allergic disease in child
- Atopic/allergic/asthma in sibling, mother or father
- PT week 34-36 or BW 2000-2500g
- Eosinophil count \>0.30 Informed consent
Age in the registry: 3 months to 24 months · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Pediatrics, Dhulikhel Hospital Coordinator of this site? Confirm its status | Dhulikhel | Nepal | Unknown status |
| Department of Paediatrics and Child Health, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.