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Completed

NCT Number: NCT01649401

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard nebulizer

Device

Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.

Other names: Micro Mist Nebulizer

PARI LC Sprint Sp nebulizer

Device

Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer.

Manufacturer: PARI GmbH Germany

Primary outcomes

  1. Length of hospitalization

    Time frame: hospital discharge (maximum of 10 days)

    The length of hospitalization in days

Secondary outcomes

  1. Duration of oxygen therapy

    Time frame: Day 0

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  2. Heart rate before the first nebulisation session

    Time frame: Day 0

    Heart rate before the first nebulisation session (bpm)

  3. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 0

    Heart rate 30 minutes after the first nebulisation session (bpm)

  4. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 0

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  5. Duration of oxygen therapy

    Time frame: Day 1

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  6. Duration of oxygen therapy

    Time frame: Day 2

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  7. Duration of oxygen therapy

    Time frame: Day 3

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  8. Duration of oxygen therapy

    Time frame: Day 4

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  9. Duration of oxygen therapy

    Time frame: Day 5

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  10. Duration of oxygen therapy

    Time frame: Day 6

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  11. Duration of oxygen therapy

    Time frame: Day 7

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  12. Duration of oxygen therapy

    Time frame: Day 8

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  13. Duration of oxygen therapy

    Time frame: Day 9

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  14. Duration of oxygen therapy

    Time frame: Day 10

    Duration of oxygen therapy (necessary to return to a saturation of > 91% when sleep, or > 94% when awake); measured in hours

  15. Heart rate before the first nebulisation session

    Time frame: Day 1

    Heart rate before the first nebulisation session (bpm)

  16. Heart rate before the first nebulisation session

    Time frame: Day 2

    Heart rate before the first nebulisation session (bpm)

  17. Heart rate before the first nebulisation session

    Time frame: Day 3

    Heart rate before the first nebulisation session (bpm)

  18. Heart rate before the first nebulisation session

    Time frame: Day 4

    Heart rate before the first nebulisation session (bpm)

  19. Heart rate before the first nebulisation session

    Time frame: Day 5

    Heart rate before the first nebulisation session (bpm)

  20. Heart rate before the first nebulisation session

    Time frame: Day 6

    Heart rate before the first nebulisation session (bpm)

  21. Heart rate before the first nebulisation session

    Time frame: Day 7

    Heart rate before the first nebulisation session (bpm)

  22. Heart rate before the first nebulisation session

    Time frame: Day 8

    Heart rate before the first nebulisation session (bpm)

  23. Heart rate before the first nebulisation session

    Time frame: Day 9

    Heart rate before the first nebulisation session (bpm)

  24. Heart rate before the first nebulisation session

    Time frame: Day 10

    Heart rate before the first nebulisation session (bpm)

  25. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 1

    Heart rate 30 minutes after the first nebulisation session (bpm)

  26. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 2

    Heart rate 30 minutes after the first nebulisation session (bpm)

  27. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 3

    Heart rate 30 minutes after the first nebulisation session (bpm)

  28. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 4

    Heart rate 30 minutes after the first nebulisation session (bpm)

  29. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 5

    Heart rate 30 minutes after the first nebulisation session (bpm)

  30. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 6

    Heart rate 30 minutes after the first nebulisation session (bpm)

  31. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 7

    Heart rate 30 minutes after the first nebulisation session (bpm)

  32. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 8

    Heart rate 30 minutes after the first nebulisation session (bpm)

  33. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 9

    Heart rate 30 minutes after the first nebulisation session (bpm)

  34. Heart rate 30 minutes after the first nebulisation session

    Time frame: Day 10

    Heart rate 30 minutes after the first nebulisation session (bpm)

  35. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 1

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  36. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 2

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  37. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 3

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  38. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 4

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  39. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 5

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  40. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 6

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  41. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 7

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  42. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 8

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  43. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 9

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  44. SpO2 saturation less thant 90% during or after nebulisation session?

    Time frame: Day 10

    Does the SpO2 saturation drop to less thant 90% during or after nebulisation session? (up to 30 minutes after the session; yes/no)

  45. Parent estimated tolerance

    Time frame: Hospital discharge (maximum 10 days)

    A visual analog scale is used to evaluate how parents estimate aerosol tolerance.

  46. Length of hospitalization according to discharge criteria

    Time frame: Hospital discharge (maximum 10 days)

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: LC SPRINT Sp

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 25, 2012
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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