Autonomic Nervous System and Sickle Cell Disease

Effect of Salbutamol on Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04062409

Acronym

DrepaSympa

Enrollment

Registered

2019-08-20

Start date

2018-01-05

Completion date

2019-05-31

Last updated

2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rate Variability (ANS Function)

Keywords

sickle cell disease; asthma; beta-agonist; hear rate variability

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

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

Design outcomes

Primary

Measure	Time frame	Description
To assess the effect of salbutamol administration on ANS in these SCD children (with and without asthma) and in control asthmatics (without SCD)	cross-sectional, one hour	heart rate variability after salbutamol administration

Secondary

Measure	Time frame	Description
To assess ANS functions in patients with SCD receiving asthma treatment or not, as compared to asthmatic children without SCD matched for ethnicity	cross-sectional, one hour	baseline heart rate variability

Countries

France

Outcome results