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

Primary Purpose

Bronchiolitis Acute Viral

Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Prednisolone Sodium Phosphate
Sugar syrup
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis Acute Viral

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SOITE LastenpäivystysRecruiting
  • OYS LastenpäivystysRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prednisolone

Placebo

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total length of hospital stay
The difference (in minutes) between the study entry and the actual time of discharge from the hospital
Intensive care unit (ICU) admissions
Proportion of children admitted to ICU
Supplemental oxygen
The total duration (in minutes) of the need for supplemental oxygen
Pediatric Early Warning Signs (PEWS) score
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.
Recurrence of wheezing
Proportion of patients with recurrence of wheezing after initial episode
Hospital re-admission
Proportion of patients with re-admission to hospital or visit to emergency department after discharge from the hospital
Proportion of patients with cough at 14 days of study entry
Proportion of patients with cough at 14 days of study entry
Duration of cough
Mean duration (in days) of cough without relapse for 3 days
Duration of cough
Mean duration (in days) of cough without relapse for 3 days
Duration of salbutamol use
Mean number of days in which salbutamol is used
Duration of respiratory distress
Mean duration (in days) of respiratory distress without relapse for 3 days
Deaths
Proportion of patients who died of any cause
Recurrence of wheezing (proportion)
Proportion of patients with recurrence of wheezing diagnosed by a physician at 2 and 12 months of study entry
Recurrence of wheezing (time)
Time (in days) to recurrence of wheezing diagnosed by a physician
Daily administrated asthma medication
Time (in days) to prescription of daily administrated asthma medication
Antibiotics and asthma medications
Purchases of antibiotics and asthma medications

Full Information

First Posted
December 22, 2021
Last Updated
October 17, 2023
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT05444699
Brief Title
Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age
Acronym
RhinoPOCRCT
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Acute Viral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone Sodium Phosphate
Intervention Description
Oral suspension administered 1 mg/kg once a day for three days
Intervention Type
Drug
Intervention Name(s)
Sugar syrup
Intervention Description
Oral suspension administered the same amount in milliliters as experimental product once a day for three days
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
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
Time Frame
Within 7 days of study entry
Secondary Outcome Measure Information:
Title
Total length of hospital stay
Description
The difference (in minutes) between the study entry and the actual time of discharge from the hospital
Time Frame
Within 7 days of study entry
Title
Intensive care unit (ICU) admissions
Description
Proportion of children admitted to ICU
Time Frame
Within 7 days of study entry
Title
Supplemental oxygen
Description
The total duration (in minutes) of the need for supplemental oxygen
Time Frame
Within 7 days of study entry
Title
Pediatric Early Warning Signs (PEWS) score
Description
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.
Time Frame
Within 7 days of study entry
Title
Recurrence of wheezing
Description
Proportion of patients with recurrence of wheezing after initial episode
Time Frame
Within 56 days of study entry
Title
Hospital re-admission
Description
Proportion of patients with re-admission to hospital or visit to emergency department after discharge from the hospital
Time Frame
Within 14 days of study entry
Title
Proportion of patients with cough at 14 days of study entry
Description
Proportion of patients with cough at 14 days of study entry
Time Frame
At 14 days of study entry
Title
Duration of cough
Description
Mean duration (in days) of cough without relapse for 3 days
Time Frame
Within 28 days of study entry
Title
Duration of cough
Description
Mean duration (in days) of cough without relapse for 3 days
Time Frame
Within 14 days of study entry
Title
Duration of salbutamol use
Description
Mean number of days in which salbutamol is used
Time Frame
Within 14 days of study entry
Title
Duration of respiratory distress
Description
Mean duration (in days) of respiratory distress without relapse for 3 days
Time Frame
Within 14 days of study entry
Title
Deaths
Description
Proportion of patients who died of any cause
Time Frame
Within 30 of study entry
Title
Recurrence of wheezing (proportion)
Description
Proportion of patients with recurrence of wheezing diagnosed by a physician at 2 and 12 months of study entry
Time Frame
Within 12 months of study entry
Title
Recurrence of wheezing (time)
Description
Time (in days) to recurrence of wheezing diagnosed by a physician
Time Frame
Within 12 months of study entry
Title
Daily administrated asthma medication
Description
Time (in days) to prescription of daily administrated asthma medication
Time Frame
Within 24 months of study entry
Title
Antibiotics and asthma medications
Description
Purchases of antibiotics and asthma medications
Time Frame
Within 24 months of study entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ville Lindholm, MD
Phone
+353405398990
Email
Ville.a.lindholm@student.oulu.fi
Facility Information:
Facility Name
SOITE Lastenpäivystys
City
Kokkola
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelli Korpela, M.D., PhD
Email
nelli.korpela@oulu.fi
Facility Name
OYS Lastenpäivystys
City
Oulu
ZIP/Postal Code
90130
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ville Lindholm, MD
Phone
+358405398990
Email
Ville.a.lindholm@student.oulu.fi
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen, MD, PhD
Phone
+358-8-315 5185
Email
terhi.tapiainen@oulu.fi
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ville Lindholm, MD
First Name & Middle Initial & Last Name & Degree
Minna Honkila, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kimmo Halt, MD
First Name & Middle Initial & Last Name & Degree
Tytti Pokka, MSc
First Name & Middle Initial & Last Name & Degree
Ulla Koskela, MD, PhD
First Name & Middle Initial & Last Name & Degree
Niko Paalanne, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tuomas Jartti, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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