Lower Respiratory Tract Infection (LRTI)Phase 4PRE-WHEENCT07858773
Prevent Wheeze Trial
A Phase 4 study testing Dexamethasone 0.6 mg/kilogram body weight single dose in people with Lower Respiratory Tract Infection (LRTI) and Recurrent Wheezing, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Lower Respiratory Tract Infection (LRTI), Recurrent Wheezing
- What is being tested?
- Dexamethasone 0.6 mg/kilogram body weight single dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2027to 30 Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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
Who cannot join
- Chronic illness other than atopy (eczema, food allergy),
- 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)
- Evidence of any bacterial infection other than bacterial LRTI, including, but not exclusively: 1. Clinical septicemia 2. Urinary tract infection 3. Meningitis
- participation in another trial
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- 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)
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Nepal1 site
Department of Pediatrics, Dhulikhel Hospital
Dhulikhel, Bagmati, 45200
Srijana Dongol, MD, +9779801315230, docsrijana@yahoo.com
Rajeev Shrestha, PhD, rajeev.shrestha@kusms.edu.np
South Africa1 site
Department of Paediatrics and Child Health, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand
Johannesburg, Gauteng, 2050
Charl Verwey, PhD, +27824118656, charl.verwey@wits.ac.za
About this study
Official title: 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.
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.
- Being tested
- Dexamethasone 0.6 mg/kilogram body weight single dose, Placebo
- Keywords
- recurrent wheezing, lower respiratory tract infection, LRTI, asthma, low- and middle-income country, LMIC, Nepal, pediatric, South Africa, dexamethasone, corticosteroids
- Medical subject headings
- Respiratory Sounds, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 0.6 mg/kilogram body weight single doseDrug
Dexamethasone 0.6 mg/kilogram body weight single dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone 0.6 mg/kilogram body weight single dose | Active comparator | Dexamethasone 0.6 mg/kilogram body weight single dose Receives: Drug: Dexamethasone 0.6 mg/kilogram body weight single dose |
| Placebo single dose | Placebo comparator | Placebo single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
New episode of wheeze within 12 months from inclusion, yes/no.
Whether or not the child had any new wheezing episode within the first 12 months. Wheeze is confirmed by doctor/study nurse or caregiver history supported by viedo. Any episode of wheeze is verified by TAL criteria scoring of 1 or more on the wheeze item (end-expiratory by stethoscope=1, Entire expiration (+/-audible without stethoscope)=2, inspiratory and expiratory (audible without stethoscope)=3). Full TAL scoring is assessed and included in episode evaluation.
Measured: 12 months
Secondary outcomes (13)
Duration of symptoms for initial episode
Measured: 6 weeks (4 - 8 weeks)
Number of episodes with breathing difficulty within 12 months
Episodes of breathing difficulty by 12 months follow-up, including: new breathing difficulty with wheeze (y/n), LRTI without wheeze (y/n), and any hospital admission for breathing difficulties (y/n).
Measured: 12 months
Time to any episode with breathing difficulties within 12 months after inclusion.
Time in number of days.
Measured: 12 months
Number of episodes with acute breathing difficulty (duration >24 hours) by 12 months.
Measured: 12 months
Total number of days with breathing difficulty within 14 days of intervention.
Measured: 14 days
Total number of days with breathing difficulty within 12 months
Measured: 12 months
Lung function at 6 weeks (4 - 8 weeks) after inclusion
Tidal breathing flow-volume loop (TBFVL) and oscillometry at scheduled visit 6 (4 - 8) weeks after inclusion.
Measured: 6 weeks
Lung function 12 months after inclusion
Tidal breathing flow-volume loop (TBFVL) and oscillometry at scheduled visit 12 months after inclusion.
Measured: 12 months
Quality of Life 6 weeks (4 - 8 weeks) after inclusion.
Quality of Life assessment in children aged 3 - 24 months in Nepal only. Nepali verison of the Pediatric Quality of Life Inventory Infant Scales (PedsQL).
Measured: 6 weeks
Quality of Life 12 months after inclusion
Quality of Life assessment in children aged 3 - 24 months in Nepal only. Nepali verison of the Pediatric Quality of Life Inventory Infant Scales (PedsQL).
Measured: 12 months
Height development within 12 months of study entry
Height is measured in centimeters (cm) to the nearest 0.1cm, using a calibrated stadiometer for children >24 months of age. For children <24 months of age, lenght is measured in the recumbent position using an infantometer. Height is measured at inclusion, 6 weeks and 12 months after inclusion.
Measured: 12 months
Body weight development within 12 months of study entry
Body weight in kilograms, 1 decimal. For children >24 months of age, weight will be measured with light clothing using a calibrated electronic scale. For children <24 months, weight will be measured without clothes or with a dry diaper only using a leveled pan scale. Body weight is measured at inclusion, 6 weeks and 12 months after inclusion.
Measured: 12 months
Time to fulfill criteria for asthma, in accordance with GINA 2025 guidelines, within 12 months.
Criteria meeting GINA 2025 definitions for asthma in children <=5 years of age: 1) symptom pattern consistent with asthma and not controlled; >=3 episodes/year or symptoms most days or 2) symptoms occurring more than two days per week with a history of severe wheezing episodes AND: response to trial treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Feb 2027 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract Infection (LRTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Drug, dexamethasone vs placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Dhulikhel Hospital, University of Witwatersrand, South Africa
- Responsible party
- Sponsor
- Investigators
- Kari R. Risnes, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858773
- Sponsor's protocol ID
- 698128
- Other IDs
- 343394
- Acronym
- PRE-WHEE
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07858773
- Acronym / sponsor ID
- PRE-WHEE / 698128
- Keywords
- recurrent wheezing, lower respiratory tract infection, LRTI, asthma, low- and middle-income country, LMIC, Nepal, pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Dhulikhel Hospital, University of Witwatersrand, South Africa
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Drug, dexamethasone vs placebo
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone 0.6 mg/kilogram body weight single dose | Active comparator | Drug: Dexamethasone 0.6 mg/kilogram body weight single doseDexamethasone 0.6 mg/kilogram body weight single dose |
| Placebo single dose | Placebo comparator | Drug: PlaceboPlacebo single dose |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (10 listed)
- Chronic illness other than atopy (eczema, food allergy),
- 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)
- Evidence of any bacterial infection other than bacterial LRTI, including, but not exclusively: 1. Clinical septicemia 2. Urinary tract infection 3. Meningitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 0.6 mg/kilogram body weight single doseDexamethasone 0.6 mg/kilogram body weight single dose | Drug | Dexamethasone 0.6 mg/kilogram body weight single dose |
| PlaceboPlacebo | Drug | Placebo single dose |
Primary outcome
New episode of wheeze within 12 months from inclusion, yes/no.
Time frame: 12 months
Whether or not the child had any new wheezing episode within the first 12 months. Wheeze is confirmed by doctor/study nurse or caregiver history supported by viedo. Any episode of wheeze is verified by TAL criteria scoring of 1 or more on the wheeze item (end-expiratory by stethoscope=1, Entire expiration (+/-audible without stethoscope)=2, inspiratory and expiratory (audible without stethoscope)=3). Full TAL scoring is assessed and included in episode evaluation.
13 secondary outcomes
Duration of symptoms for initial episode
Time frame: 6 weeks (4 - 8 weeks)
Number of episodes with breathing difficulty within 12 months
Time frame: 12 months
Time to any episode with breathing difficulties within 12 months after inclusion.
Time frame: 12 months
Number of episodes with acute breathing difficulty (duration >24 hours) by 12 months.
Time frame: 12 months
Total number of days with breathing difficulty within 14 days of intervention.
Time frame: 14 days
Total number of days with breathing difficulty within 12 months
Time frame: 12 months
Lung function at 6 weeks (4 - 8 weeks) after inclusion
Time frame: 6 weeks
Lung function 12 months after inclusion
Time frame: 12 months
Quality of Life 6 weeks (4 - 8 weeks) after inclusion.
Time frame: 6 weeks
Quality of Life 12 months after inclusion
Time frame: 12 months
Height development within 12 months of study entry
Time frame: 12 months
Body weight development within 12 months of study entry
Time frame: 12 months
Time to fulfill criteria for asthma, in accordance with GINA 2025 guidelines, within 12 months.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kari R. Risnes, PhD principal investigator
Norwegian University of Science and Technology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone 0.6 mg/kilogram body weight single dose in people with Lower Respiratory Tract Infection (LRTI) and Recurrent Wheezing, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kari R Risnes, PhD (+4795170397, kari.risnes@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New episode of wheeze within 12 months from inclusion, yes/no. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.