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CompletedNCT05555134Updated Sep 9, 2026

INHALATION CHAMBER MANAGEMENT IN PEDIATRICS: EFFICACY OF AN EDUCATIONAL INTERVENTION IN PATIENTS DIAGNOSED WITH BRONCHOSPASM AND THEIR FAMILY CAREGIVERS.

An interventional study of educational intervention in Bronchospasm, sponsored by Puerta de Hierro University Hospital. Completed at 1 site in Spain. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Puerta de Hierro University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
2 Years to 15 Years
Sex
All
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Study summary

Several studies show that unnecessary and frequent visits to the emergency department for bronchospasm care are associated with inadequate management of inhalers and poor education on the approach to respiratory distress. Main objective: To determine the degree of frequentation to the pediatric emergency department for bronchospasm at 1, 3, 6 and 12 months after the educational intervention. Design: Randomized controlled clinical trial with two groups: EXPERIMENTAL will receive the educational intervention, along with usual care, and CONTROL will receive usual care. Subjects: pediatric patients (2-15 years) diagnosed with bronchospasm; in home treatment with inhalation chambers; and their parents. Emergency Department recruitment. Follow-up at home

02

Conditions studied

  • Bronchospasm

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03

In context

Bronchial Spasm

44 studies on the registry are indexed under Bronchial Spasm; 4 are open to participants now.

This study's enrollment of 134 is above the median of 70 across 29 interventional studies indexed under Bronchial Spasm.

Browse Bronchial Spasm studies →

Lead sponsor

Puerta de Hierro University Hospital is the lead sponsor of 48 studies on the registry; 12 are open to participants now.

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

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Who can participate

Ages eligible
2 Years to 15 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

  • Patients between 2-15 years of age attending the Pediatric Emergency Department of the Hospital Universitario Puerta de Hierro Majadahonda (HUPHM) with a mild, moderate or severe bronchospasm crisis and who have used the inhalation chambers on at least one occasion; with autonomy in the use of the inhalation chambers at home

Exclusion criteria

Exclusion Criteria:

  • Not understanding Spanish
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
134 participants (actual)

Study arms

  • No intervention
    CONTROL

    receive usual care

  • Experimental
    EXPERIMENTAL

    receive the educational intervention, along with usual care

    Behavioral: educational intervention

Interventions

  • Behavioraleducational intervention

    will also have an extra educational intervention, a group intervention (4-6 people) through a one-hour training session via zoom, which will be given by the PI (extensive experience in the subject) a week after discharge from the ER. Information will be reinforced and doubts will be solved

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What researchers measure

Primary outcomes

  1. Number of pediatric emergency department revisits for bronchospasm

    Time frame: 1, 3, 6, and 12 months after enrollment

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Study locations

1 site
  • Belén de la Rosa
    Majadahonda, Madrid 28222, Spain
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Jan 2025, 23 months.

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

Registered
Sep 19, 2022
First posted
Sep 26, 2022
StartActual
Jan 10, 2023
Primary completionActual
Jan 1, 2025
CompletionActual
May 31, 2025
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
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.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05555134
Lead sponsor
Puerta de Hierro University Hospital
Responsible party
Belén de la Rosa (Belén de la Rosa Roch, Puerta de Hierro University Hospital) — Principal investigator
First posted
Sep 26, 2022
Start date
Jan 10, 2023
Primary completion
Jan 1, 2025
Completion
May 31, 2025
Last update
Sep 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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