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Autonomic Nervous System and Sickle Cell Disease (DrepaSympa)

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ClinicalTrials.gov Identifier: NCT04062409
Recruitment Status : Completed
First Posted : August 20, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date August 19, 2019
First Posted Date August 20, 2019
Last Update Posted Date November 18, 2019
Actual Study Start Date January 5, 2018
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2019)
To assess the effect of salbutamol administration on ANS in these SCD children (with and without asthma) and in control asthmatics (without SCD) [ Time Frame: cross-sectional, one hour ]
heart rate variability after salbutamol administration
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2019)
To assess ANS functions in patients with SCD receiving asthma treatment or not, as compared to asthmatic children without SCD matched for ethnicity [ Time Frame: cross-sectional, one hour ]
baseline heart rate variability
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Autonomic Nervous System and Sickle Cell Disease
Official Title Effect of Salbutamol on Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease
Brief Summary Sickle cell disease (SCD) children and adults with asthma have an increased rate of vaso-occlusive crisis, acute chest syndrome episodes, and premature mortality when compared to those without asthma. We hypothesised that either asthma diagnosis and/or bronchodilator treatment may aggravate SCD via their modulating effect on autonomic nervous system.
Detailed Description Heart rate variability during pulmonary function tests (spirometry, static volumes, DLCO/DLNO, exhaled NO at multiple flow rates) including salbutamol administration will be evaluated in patients with SCD (n=60) receiving asthma treatment or not, as compared to asthmatic children without SCD (n=30) matched for ethnicity
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects of African or Caribbean ethnicity who were 8 to 16 years of age and were referred to the Pulmonary function Testing unit for the follow-up of their disease : SCD or asthma
Condition Heart Rate Variability (ANS Function)
Intervention Not Provided
Study Groups/Cohorts
  • Sickle cell patients
  • Asmathic patients
Publications * Bokov P, El Jurdi H, Denjoy I, Peiffer C, Medjahdi N, Holvoet L, Benkerrou M, Delclaux C. Salbutamol Worsens the Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease. Front Physiol. 2020 Feb 26;11:31. doi: 10.3389/fphys.2020.00031. eCollection 2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 19, 2019)
90
Original Actual Enrollment Same as current
Actual Study Completion Date May 31, 2019
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age from 8 to 16 years (≥ 8 years and < 16 years) (spirometry and DLCO study feasible)
  • Sub-Saharan African or Caribbean ethnic origin.
  • child with sickle cell disease referred for monitoring of respiratory function in the framework of its sickle cell disease and whether or not it presents a possible disease asthmatic (asthma treatment prescribed in the past year)
  • or asthmatic child (typical functional signs + history of exacerbation severe hospitalized or reversible obstructive pulmonary disorder) not sickle cell
  • addressed for respiratory function monitoring

Exclusion Criteria:

  • Refusal to participate (lack of consent)
  • Sickle cell child of North African origin
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 16 Years   (Child)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04062409
Other Study ID Numbers K170302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Christophe Delclaux, MD PhD APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2019