NCT05444699

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
16mo left

Started Oct 2022

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Oct 2022Sep 2027

First Submitted

Initial submission to the registry

December 22, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

4.1 years

First QC Date

December 22, 2021

Last Update Submit

February 11, 2025

Conditions

Bronchiolitis Acute Viral

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    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

    Within 7 days of study entry

Secondary Outcomes (16)

  • Total length of hospital stay

    Within 7 days of study entry

  • Intensive care unit (ICU) admissions

    Within 7 days of study entry

  • Supplemental oxygen

    Within 7 days of study entry

  • Pediatric Early Warning Signs (PEWS) score

    Within 7 days of study entry

  • Recurrence of wheezing

    Within 56 days of study entry

  • +11 more secondary outcomes

Study Arms (2)

Prednisolone

EXPERIMENTAL

Prednisolone Sodium Phosphate (25 mg/5 mL) oral suspension administered 1 mg/kg\* (up to 20 mg = 4 mL) once a day for 3 days. \*(0-5 kg: 5 mg; 5.01-7.5 kg: 7.5 mg; 7.51-10 kg: 10 mg; 10.01-12.5 kg: 12.5 mg; 12.51-15 kg: 15 mg; 15.01-17.5 kg: 17.5 mg; ≥ 17.51 kg: 20 mg)

Drug: Prednisolone Sodium Phosphate

Placebo

PLACEBO COMPARATOR

Sugar syrup oral suspension containing saccharum 630-640 mg/g and aqua purificata 360-370 mg/g administered the same amount in milliliters as experimental product (up to 4 mL) once a day for 3 days.

Drug: Sugar syrup

Interventions

Prednisolone Sodium PhosphateDRUG

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

Prednisolone
Sugar syrupDRUG

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

Placebo

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SOITE Lastenpäivystys

Kokkola, Finland

RECRUITING

OYS Lastenpäivystys

Oulu, 90130, Finland

RECRUITING

MeSH Terms

Interventions

prednisolone phosphateHigh Fructose Corn Syrup

Intervention Hierarchy (Ancestors)

Dietary SugarsDietary CarbohydratesCarbohydratesSugarsNutritive SweetenersSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Ville Lindholm, MD

CONTACT

+35883155283Ville.a.lindholm@oulu.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics, Head of Pediatric Infectious Diseases and Emergency Department

Study Record Dates

First Submitted

December 22, 2021

First Posted

July 6, 2022

Study Start

October 11, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)