CroupPhase 4NCT01042145

Community Care for Croup (RCT)

A Phase 4 study testing Prednisone and Dexamethasone in people with Croup, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 1 year to 8 years
Conditions the study is for: Croup
What is being tested?: Prednisone and Dexamethasone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Jun 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

children aged 1 to 8 years old (not yet reached their 9th birthday), who have croup symptoms for less than or equal to 48 hours and have a physician diagnosis of mild or moderate croup.

Who cannot join

Severe croup or impending respiratory failure;
another reason to indicate the need for hospitalization;
symptoms or signs to suggest another cause of stridor;
active varicella infection;
diabetes;
known immunodeficiency disease;

Show all 14Show fewer

chronic respiratory disease such as CF (Cystic Fibrosis);
prescribed a controller medication or oral steroids for asthma in the past 12 months;
a history of TB(tuberculosis) in a household member;
treatment for seizures;
treatment with epinephrine or oral corticosteroids for this croup episode before enrollment;
not accompanied by their legal guardian;
the accompanying adult will not be in the same household as the child for the next four days;
parent/legal guardian is unavailable for telephone follow-up or does not speak English.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

This randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for 3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate croup. It was conducted in a practice-based research network of community pediatricians in the St. Louis area. Outcomes included additional health care for croup, duration of symptoms, nights of disturbed sleep, parental stress, missed work days, and adverse events. Our hypothesis was that community-based treatment of children with mild or moderate croup with multiple doses of prednisone is superior to a single dose of dexamethasone.

Conditions: Croup
Being tested: Prednisone, Dexamethasone
Keywords: Primary Care, Treatment, Croup, Corticosteroids, Prednisone, Dexamethasone, Randomized trial
Medical subject headings: Croup

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrednisoneDrug
2 mgs/kg for 3 days
DexamethasoneDrug
0.6 mgs for one day, then placebo for 2 days

Study groups in NCT01042145
Study group	Role	What they receive
Prednisone	Active comparator	Prednisone, 2mg/kg for 3 days Receives: Drug: Prednisone
Dexamethasone	Active comparator	Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days Receives: Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Additional Health Care
The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care.
Measured: 11 days

Secondary outcomes (5)

Duration of Croup Symptoms
Measured: 12 days
Nights With Disturbed Sleep
Measured: 12 days
Parental Stress
Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0.
Measured: 12 days
Time Missed From Work
Measured: 12 days
Number of Participants With Reported Side Effects
Measured: 12 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Jun 2011

First posted5 Jan 2010 (estimated)
Study startOct 2009
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CroupStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01042145
Sponsor's protocol ID: 09-0542
Other IDs: NIH/NCRR UL1RR024992
Status last verified: Sep 2014
First submitted: 4 Jan 2010
Last updated: 15 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Garbutt JM, Conlon B, Sterkel R, Baty J, Schechtman KB, Mandrell K, Leege E, Gentry S, Stunk RC. The comparative effectiveness of prednisolone and dexamethasone for children with croup: a community-based randomized trial. Clin Pediatr (Phila). 2013 Nov;52(11):1014-21. doi: 10.1177/0009922813504823. Epub 2013 Oct 3.
PubMed 24092872

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Complicated Infections in Otorhinolaryngology
Sinusitis, Otitis
Recruiting
Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care
Angina, Acute Bronchiolitis
RecruitingPhase 3
VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma
Asthma, Respiratory Tract Infections
RecruitingPhase 3
Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma
Asthma, Respiratory Tract Infections

All Croup trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community Care for Croup (RCT)
ClinicalTrials.gov ID: NCT01042145
Acronym / sponsor ID: 09-0542
Conditions: Croup
Keywords: Primary Care, Treatment, Croup, Corticosteroids, Prednisone, Dexamethasone, Randomized trial
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Washington University Pediatric and Adolescent Ambulatory Research Consortium
Study start: Oct 2009
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 5 Jan 2010 (estimated)
Results: Posted 15 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Prednisone	Active comparator	Drug: PrednisonePrednisone, 2mg/kg for 3 days
Dexamethasone	Active comparator	Drug: DexamethasoneDexamethasone, 0.6mg/kg for one day, then placebo for 2 days

Who may qualify

Ages: 1 year to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

children aged 1 to 8 years old (not yet reached their 9th birthday), who have croup symptoms for less than or equal to 48 hours and have a physician diagnosis of mild or moderate croup.

Key exclusion criteria (14 listed)

Severe croup or impending respiratory failure;
another reason to indicate the need for hospitalization;
symptoms or signs to suggest another cause of stridor;
active varicella infection;
diabetes;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prednisone2 mgs/kg for 3 days	Drug	Prednisone
Dexamethasone0.6 mgs for one day, then placebo for 2 days	Drug	Dexamethasone

Primary outcome

Additional Health Care
Time frame: 11 days
The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care.

5 secondary outcomes

Duration of Croup Symptoms
Time frame: 12 days
Nights With Disturbed Sleep
Time frame: 12 days
Parental Stress
Time frame: 12 days
Time Missed From Work
Time frame: 12 days
Number of Participants With Reported Side Effects
Time frame: 12 days

Results and safety

Results posted to the registry on 15 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prednisone	41	40
Dexamethasone	46	45

Primary outcome: Additional Health Care

Time frame: 11 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Prednisone n = 40	Dexamethasone n = 45
Value	7 (1.5 to 19.9)	2 (0 to 11.5)

Prednisone vs Dexamethasone: p = 0.34, Fisher Exact

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prednisone	0 of 41 (0%)	0 of 41 (0%)	Not reported
Dexamethasone	0 of 46 (0%)	0 of 46 (0%)	Not reported

Limitations and caveats (from the sponsor): Our failure to demonstrate any difference bewteen the two study groups may be due to the small sample size. We were unable to recruit the targeted sample size of 200.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24092872Garbutt JM, Conlon B, Sterkel R, Baty J, Schechtman KB, Mandrell K, Leege E, Gentry S, Stunk RC. The comparative effectiveness of prednisolone and dexamethasone for children with croup: a community-based randomized trial. Clin Pediatr (Phila). 2013 Nov;52(11):1014-21. doi: 10.1177/0009922813504823. Epub 2013 Oct 3.

Related trials for Croup

RecruitingObservational study
Complicated Infections in Otorhinolaryngology
Sinusitis, Otitis
Recruiting
Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care
Angina, Acute Bronchiolitis
RecruitingPhase 3
VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma
Asthma, Respiratory Tract Infections
RecruitingPhase 3
Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma
Asthma, Respiratory Tract Infections

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jane M Garbutt, MB, ChB principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prednisone and Dexamethasone in people with Croup, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Additional Health Care (time frame: 11 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01042145, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.