Clinical trial NCT04062409: Autonomic Nervous System and Sickle Cell Disease
Official title: Effect of Salbutamol on Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate Variability (ANS Function)
Keywords: sickle cell disease; asthma; beta-agonist; hear rate variability
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

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

Primary outcomes:
measure: To assess the effect of salbutamol administration on ANS in these SCD children (with and without asthma) and in control asthmatics (without SCD)
timeFrame: cross-sectional, one hour
Secondary outcomes:
measure: To assess ANS functions in patients with SCD receiving asthma treatment or not, as compared to asthmatic children without SCD matched for ethnicity
timeFrame: cross-sectional, one hour
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: APHP
name: Christophe Delclaux, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.