Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jul 24, 2012
Trial Information
Current as of May 23, 2025
Completed
Keywords
ClinConnect Summary
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 fo...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • The parent or legal representative must have given his/her informed and signed consent
- • The patient must be insured or beneficiary of a health insurance plan
- * The patient has an attack of moderate to severe asthma (at least the third episode of wheezing dyspnea since birth) requiring hospitalization defined by the following criteria:
- • requires oxygen: SpO2 \<92% on room air (if CAS ≤ 4/10)
- • And / or CAS\> 4/10 (after 3 attempted nebulized salbutamol sessions over 1 hour of emergency care).
- Exclusion Criteria:
- • The patient is participating in another study
- • The patients has already been included in this study a previous time
- • The patient is in an exclusion period determined by a previous study
- • The patient is under judicial protection, under tutorship or curatorship
- • The parent or legal representative refuses to sign the consent
- • It is impossible to correctly inform the parent or legal representative
- • The patient has a contra indication for a treatement used in this study
- • Patient was born at \< 34 weeks of pregnancy or bronchdysplasic
- • First or second episode of bronchiolitis
- • Asthma attack with CAS score ≤ 4/10 or inpatient basis for a non-breathing related motive.
- • Acute severe Asthma attack: hypercapnia, impaired consciousness, need for hospitalization in intensive care, need for mechanical ventilation, need for salbutamol IV
- • Patient with known congenital heart disease
- • Patient with chronic respiratory disease other than asthma
- • Patient with encephalopathy
- • Patient with known immune deficiency
- • CAS ≤ 2 and transcutaneous oxygen saturation (SpO2)\> 94% when awake or \> 91% when asleep for at least 12h
About Centre Hospitalier Universitaire De Nīmes
The Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) is a leading academic medical center located in Nîmes, France, dedicated to advancing healthcare through innovative clinical research and patient care. As a prominent sponsor of clinical trials, CHU Nîmes collaborates with a multidisciplinary team of healthcare professionals and researchers to conduct rigorous studies aimed at improving treatment outcomes and enhancing medical knowledge across various specialties. With a strong commitment to ethical standards and patient safety, CHU Nîmes fosters a research environment that encourages scientific excellence and contributes to the development of new therapies and healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nîmes Cedex 09, , France
Patients applied
Trial Officials
Lucie Gilton-Bott, MD
Principal Investigator
Centre Hospitalier Universitaire de Nîmes
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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