PRE-WHEE
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.
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · The Research Council of Norway
interventional
486
2 countries
2
Study Start
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2026
Actual (reported)October 5, 2026
Actual (reported)February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
12 months
Duration of symptoms for initial episode
6 weeks (4 - 8 weeks)
Number of episodes with breathing difficulty within 12 months
Dexamethasone 0.6 mg/kilogram body weight single dose
Placebo single dose
Dexamethasone 0.6 mg/kilogram body weight single dose
Placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Pediatrics, Dhulikhel Hospital
Dhulikhel, Bagmati, 45200, Nepal
Department of Paediatrics and Child Health, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand
Johannesburg, Gauteng, 2050, South Africa
Kari R. Risnes, PhD
Norwegian University of Science and Technology
First Submitted
September 24, 2026
First Posted
October 5, 2026
Study Start
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
12 months
Time to any episode with breathing difficulties within 12 months after inclusion.
12 months
Number of episodes with acute breathing difficulty (duration >24 hours) by 12 months.
12 months
Total number of days with breathing difficulty within 14 days of intervention.
14 days
Contact the study team to confirm eligibility.
Primary Completion
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 5, 2026
Record last verified: 2026-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: