ClinicalTrials.gg
CompletedNCT00230841Updated Aug 2, 2013

Comparing Different Ways of Delivering Humidity to Children With Croup

A Phase 2 interventional study of nebulized humidity in Croup, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 3 Months to 10 Years. Per ClinicalTrials.gov, last updated 2013-08-02.

Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
3 Months to 10 Years
Sex
All
01

Study summary

Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. This study will compare the effectivenesss of 40% and 100% humidity through a specially designed machine called a nebulizer, with the usual humidity set-up (blown into the patient's face from a hose).

02

Conditions studied

  • Croup

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Keywords

  • croup
  • humidity therapy
  • pediatrics
03

In context

Croup

18 studies on the registry are indexed under Croup; 2 are open to participants now.

This study's enrollment of 129 is above the median of 86 across 12 interventional studies indexed under Croup.

Browse Croup studies →

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • children aged 3 months - 10 years
  • croup score greater than or equal to 2 after a 30 minute waiting period

Exclusion criteria

Exclusion Criteria:

  • Symptoms of croup requiring immediate intervention with nebulized epinephrine or intubation
  • symptoms or signs of alternative causes of stridor
  • inability of caregivers to understand or speak English and/or sign for
  • history of chronic pulmonary disease except for asthma, or co-existent systemic disease
  • previous history of intubation
  • duration of present illness >1 week
  • systemic or inhaled in previous 48 hours
  • epinephrine in previous 4 hours
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
129 participants

Interventions

  • Devicenebulized humidity
06

What researchers measure

Primary outcomes

  1. changes in the croup score from baseline to 30 and 60 minutes

Secondary outcomes

  1. steroid or epinephrine treatment at 60 minutes

  2. discharge rate at 60 minutes

  3. change in pulse, respiratory rate, and oxygen saturation at 60 minutes

07

Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
08

References and documents

Publications

  • Scolnik D, Coates AL, Stephens D, Da Silva Z, Lavine E, Schuh S. Controlled delivery of high vs low humidity vs mist therapy for croup in emergency departments: a randomized controlled trial. JAMA. 2006 Mar 15;295(11):1274-80. doi: 10.1001/jama.295.11.1274. PubMed 16537737 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2001 and a completion of Apr 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2005
First posted
Oct 3, 2005
Start
Sep 2001
Completion
Apr 2004
Last update
Aug 2, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Aug 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00230841
Collaborators
The Physicians' Services Incorporated Foundation
Responsible party
Dennis Scolnik (Staff Physician, The Hospital for Sick Children) — Principal investigator
First posted
Oct 3, 2005
Start date
Sep 2001
Completion
Apr 2004
Last update
Aug 2, 2013

Study contacts

Dennis Scolnik, MD
principal investigator · The Hospital for Sick Children, Toronto Canada
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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