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RECRUITING
NCT03889743
PHASE4

Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing

Sponsor: St. Olavs Hospital

View on ClinicalTrials.gov

Summary

The overall objective of the study is to determine the efficacy of corticosteroids in preventing recurrent wheezing and asthma in high-risk, first-time severe wheezing children with rhinovirus infection, stratified by rhinovirus genome load. The secondary objectives are to determine duration and severity of each acute episode with acute expiratory breathing difficulty, the number of episodes with acute expiratory breathing difficulty, degree of pulmonary hyperreactivity and quality of life within 24 months after study entry.

Official title: Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing - the INSTAR Study

Key Details

Gender

All

Age Range

3 Months - 23 Months

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2019-05-08

Completion Date

2028-05

Last Updated

2025-06-13

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone treatment during 3 days

Dexamethasone 1,0 mg oral tablets. The exact daily dose of dexamethasone will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.

DRUG

placebo treatment during 3 days

1,0 mg oral tablets. The exact daily dose of lactose (instead of dexamethasone) will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.

Locations (8)

Turku University Hospital

Turku, Finland

Haukeland University Hospital

Bergen, Norway

Akershus University Hospital

Oslo, Norway

Ullevål University Hospital

Oslo, Norway

Stavanger University Hospital

Stavanger, Norway

University Hospital of North Norway

Tromsø, Norway

St Olavs Hospital

Trondheim, Norway

Karolinska Universitetssjukhuset

Stockholm, Sweden