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Prevent Wheeze Trial

ConditionsLower Respiratory Tract Infection (LRTI)Recurrent Wheezing
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-24
SponsorNorwegian University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 3-24 months

LRTI (WHO definition LRTI: Cough or difficulties breathing

No history of previous LRTI/wheeze

Clinical wheeze by presentation (indicated in TAL score>=1 for wheeze item). The scoring matrix is here and in the annex.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone 0.6 mg/kilogram body weight single dose

    Drug

    Dexamethasone 0.6 mg/kilogram body weight single dose

  • Placebo

    Drug

    Placebo

Treatment groups

486 Participants
are divided into 2 treatment groups
Group A: Dexamethasone 0.6 mg/kilogram body weight single doseActive comparator 1 intervention
Group B: Placebo single dosePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

Duration of symptoms for initial episode

Time frame
6 weeks (4 - 8 weeks)
2

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).

Time frame
12 months
3

Time to any episode with breathing difficulties within 12 months after inclusion.

Time in number of days.

Time frame
12 months
4

Number of episodes with acute breathing difficulty (duration >24 hours) by 12 months.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Norwegian University of Science and Technology

Lead sponsor

Dhulikhel Hospital

Collaborator

University of Witwatersrand, South Africa

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: