Trial Outcomes & Findings for Community Care for Croup (RCT) (NCT NCT01042145)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

87 participants

Primary outcome timeframe

11 days

Results posted on

2014-09-15

Participant Flow

Children were recruited from 10 primary care pediatric practices over two winters: between October 26, 2009 and April 16, 2010; and between September 6, 2010 and April 29, 2011.

103 children were assessed for eligibility. 16 were excluded prior to randomization. reasons were: did not meet inclusion criteria (10), declined to participte (6).

Participant milestones

Participant milestones
Measure	Prednisone	Dexamethasone
Overall Study STARTED	41	46
Overall Study COMPLETED	40	45
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Community Care for Croup (RCT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prednisone n=41 Participants	Dexamethasone n=46 Participants	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	41 Participants n=5 Participants	46 Participants n=7 Participants	87 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	2.67 years STANDARD_DEVIATION 1.43 • n=5 Participants	3.11 years STANDARD_DEVIATION 1.58 • n=7 Participants	2.9 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	46 participants n=7 Participants	87 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prednisone n=40 Participants	Dexamethasone n=45 Participants
Additional Health Care	7 percentage of participants Interval 1.5 to 19.9	2 percentage of participants Interval 0.0 to 11.5

SECONDARY outcome

Timeframe: 12 days

Outcome measures

Outcome measures
Measure	Prednisone n=40 Participants	Dexamethasone n=45 Participants
Duration of Croup Symptoms	2.2 days Standard Deviation 1.3	2.8 days Standard Deviation 2.7

SECONDARY outcome

Timeframe: 12 days

Outcome measures

Outcome measures
Measure	Prednisone n=40 Participants	Dexamethasone n=45 Participants
Nights With Disturbed Sleep	1.21 nights Standard Deviation 2.69	0.68 nights Standard Deviation 1.55

SECONDARY outcome

Timeframe: 12 days

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.

Outcome measures

Outcome measures
Measure	Prednisone n=40 Participants	Dexamethasone n=45 Participants
Parental Stress	1.56 days Standard Deviation 2.69	1.39 days Standard Deviation 1.08

SECONDARY outcome

Timeframe: 12 days

Outcome measures

Outcome measures
Measure	Prednisone n=40 Participants	Dexamethasone n=45 Participants
Time Missed From Work	3.79 Hours Standard Deviation 7.40	4.06 Hours Standard Deviation 5.54

SECONDARY outcome

Timeframe: 12 days

Outcome measures

Outcome measures
Measure	Prednisone n=40 Participants	Dexamethasone n=45 Participants
Number of Participants With Reported Side Effects	26 percentage of participants	24 percentage of participants

Adverse Events

Prednisone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jane Garbutt

Washington University School of Medicine

Phone: 314-454-8613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place