NCT01649401

Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to determine whether the use of the PARI LC Sprint Sp nebulizer in the treatment of asthma in children under 36 months reduces the duration of hospitalization.

Detailed description

The secondary objectives of this study are to evaluate whether the use of the LC Sprint Sp Nebulizer results in: A-shortened duration of oxygen-dependence. B-reduced side effects by assessing the patient's heart rate before and 30 minutes after the first aerosol and noting the occurrence of desaturation \<90% during the nebulisation sessions. C-increased acceptance of the aerosol, measured via a questionnaire given to the patient's parents at the end of hospitalization (a single questionnaire will be completed by either parent or both parents). D-shortened length of stay based on the following discharge criteria: observation of a respiratory severity score ≤ 2 (Clinical Asthma Score (CAS)) for at least 12 consecutive hours and a transcutaneous oxygen saturation (SpO2)\> 94% when awake or \> 91% during sleep.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	Standard nebulizer	Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.
DEVICE	PARI LC Sprint Sp nebulizer	Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer. Manufacturer: PARI GmbH Germany

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-11-04
• Completion: 2016-11-04
• First posted: 2012-07-25
• Last updated: 2017-02-01

Locations

1 site across 1 country: France