Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05444699

Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age

The aim of the trial is to evaluate whether the use of oral prednisolone directed by point-of-care testing is useful in acute wheezing caused by rhinovirus in children aged 6-24 months.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Bronchiolitis Acute Viral

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SOITE Lastenpäivystys, Kokkola, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Wheezing bronchitis diagnosed by a physician
  • Need for salbutamol treatment at the emergency department
  • Positive nasopharyngeal rhinovirus or picornavirus finding in point-of-care testing

Exclusion criteria

  • Need for immediate resuscitation
  • Immediate transfer to ICU
  • Suspected pneumonia based on the auscultation finding
  • Suspected serious bacterial infection
  • Other respiratory virus finding in the absence of rhinovirus or picornavirus
  • Positive respiratory syncytial virus finding
  • Positive SARS-coronavirus-2 finding
  • Positive Mycoplasma pneumoniae finding
  • Positive Bordetella pertussis finding
  • Contact with a person with chickenpox within 14 days
  • Active chickenpox
  • Suspected foreign body of the respiratory tract
  • Immunosuppressive treatment
  • Systemic corticosteroid treatment within 14 days
  • Allergy to corticosteroids

Treatment and study plan

Prednisolone Sodium Phosphate

Drug

Oral suspension administered 1 mg/kg once a day for three days

Sugar syrup

Drug

Oral suspension administered the same amount in milliliters as experimental product once a day for three days

Primary outcomes

  1. Length of hospital stay

    Time frame: Within 7 days of study entry

    The difference (in minutes) between the study entry and the time that the patient is deemed to be fit for discharge (sign off for discharge)

    Subgroup analyses for the primary outcome are performed in following subgroups:

    • Children presenting with first episode of wheezing
    • Children with at least one previous episode of wheezing diagnosed by a physician
    • Children with a cycle threshold number of < 30 for detected picornavirus
    • Children with a cycle threshold number of 30-37 for detected picornavirus
    • Children with a cycle threshold number of 38-40 for detected picornavirus

Secondary outcomes

  1. Total length of hospital stay

    Time frame: Within 7 days of study entry

    The difference (in minutes) between the study entry and the actual time of discharge from the hospital

  2. Intensive care unit (ICU) admissions

    Time frame: Within 7 days of study entry

    Proportion of children admitted to ICU

  3. Supplemental oxygen

    Time frame: Within 7 days of study entry

    The total duration (in minutes) of the need for supplemental oxygen

  4. Pediatric Early Warning Signs (PEWS) score

    Time frame: Within 7 days of study entry

    Maximum decrease in PEWS score within 12 hours after study entry. PEWS scores range from 0 to 32 depending on the child's respiratory rate, work of breathing, saturation of peripheral oxygen, need for supplemental oxygen, blood pressure, heart rate, capillary refill and level of consciousness. 0 refers to low and > 7 to high risk of deterioration.

  5. Recurrence of wheezing

    Time frame: Within 56 days of study entry

    Proportion of patients with recurrence of wheezing after initial episode

  6. Hospital re-admission

    Time frame: Within 14 days of study entry

    Proportion of patients with re-admission to hospital or visit to emergency department after discharge from the hospital

  7. Proportion of patients with cough at 14 days of study entry

    Time frame: At 14 days of study entry

    Proportion of patients with cough at 14 days of study entry

  8. Duration of cough

    Time frame: Within 28 days of study entry

    Mean duration (in days) of cough without relapse for 3 days

  9. Duration of cough

    Time frame: Within 14 days of study entry

    Mean duration (in days) of cough without relapse for 3 days

  10. Duration of salbutamol use

    Time frame: Within 14 days of study entry

    Mean number of days in which salbutamol is used

  11. Duration of respiratory distress

    Time frame: Within 14 days of study entry

    Mean duration (in days) of respiratory distress without relapse for 3 days

  12. Deaths

    Time frame: Within 30 of study entry

    Proportion of patients who died of any cause

  13. Recurrence of wheezing (proportion)

    Time frame: Within 12 months of study entry

    Proportion of patients with recurrence of wheezing diagnosed by a physician at 2 and 12 months of study entry

  14. Recurrence of wheezing (time)

    Time frame: Within 12 months of study entry

    Time (in days) to recurrence of wheezing diagnosed by a physician

  15. Daily administrated asthma medication

    Time frame: Within 24 months of study entry

    Time (in days) to prescription of daily administrated asthma medication

  16. Antibiotics and asthma medications

    Time frame: Within 24 months of study entry

    Purchases of antibiotics and asthma medications

Study contacts

Contact information is provided by the study sponsor or research team.

Ville Lindholm, MD

CONTACT

[email protected]

+35883155283

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial

Acronym: RhinoPOCRCT

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.