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NCT01042145 · ClinicalTrials.gov registry record · Phase 4

Community Care for Croup (RCT)

A Phase 4 study of Croup, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 4
Development phase
87
Enrollment target
1
Study location

NCT01042145: Completed Phase 4 study of Croup, sponsored by Washington University School of Medicine.

NCT01042145 is a Phase 4 study of Croup that has completed, run by Washington University School of Medicine. The registered enrollment target is 87 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01042145, a Phase 4 study of Croup, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 4
Development phase
87 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Dexamethasone
  • DRUG Prednisone

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 87 participants
Start Date 2009-10
Est. Completion 2011-06
Phase Phase 4

What the finished NCT01042145 record still lists

NCT01042145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).

The record links to 1 condition, with Croup appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.

NCT01042145 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT01042145 about?

NCT01042145 is a clinical study titled "Community Care for Croup (RCT)". 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. Outc...

What is the current status of trial NCT01042145?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 87 participants. The study started on 2009-10. Estimated completion is 2011-06.

What conditions does trial NCT01042145 study?

This clinical trial studies the following conditions: Croup.

What interventions are being tested in trial NCT01042145?

The interventions under investigation include: Dexamethasone (DRUG), Prednisone (DRUG).

Who is sponsoring clinical trial NCT01042145?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01042145 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01042145's enrollment target sits among peer trials

87 923rd of 2000 higher than 1,075 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01042145, the US trial registry maintained by the National Library of Medicine. NCT01042145 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.