Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: Macroduct® Advanced Model 3710 SYS, Wescor

• Registration Number: NCT03913507
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

In nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that does not meet international recommendations and is insufficient to allow reliable and reproducible biological analyzes in the sweat collected. In children between 3 and 12 months, this rate is about 10% when it should not exceed 5%. Insufficient amount of sweat prevents confirmation or reversal of the early diagnosis of cystic fibrosis and early treatment before irreversible complications of the disease.

In this trial, a new support of sweat collection (Macroduct® Advanced Model 3710 Sweat Collection System, Wescor) will be tested with the goal to increase the amount of sweat collected during the sweat test, in comparison with the clinical routine method.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-14
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-12
• Primary Completion: 2020-12-31
• Status Verified: 2021-03
• Study Completion: 2021-03-22
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Subject aged of 2 days to 12 months
• Indication of a sweat test prescribed by a clinician in a context of neonatal screening
• Clinically stable
• Well hydrated
• Not under treatment with mineralocorticoids

Exclusion Criteria

• Subjects weighing less than 2 kg
• Subjects less than 48 hours old
• Presence of an acute infectious condition
• Presence of mineralocorticoid treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one group : patients with suspicion of cystic fibrosis	Macroduct® Advanced Model 3710 SYS, Wescor	-

Primary Outcome Measures

Name	Time	Method
chloride concentration	day 1	The volume and the chloride concentration will be analyzed for each subject.

Secondary Outcome Measures

Name	Time	Method
sweat	day 1	sweat collected with sweat collection method (Macroduct® Advanced) Model 3710 SYS, Wescor) compared with that currently used in clinical routine.; The effectiveness criterion of the new Macroduct Advanced collector will be defined as follows: the new device tested will be considered effective if the insufficient amount of sweat levels obtained are smaller or equal to those recommended, i.e. if it is lower than 10% in children under 3 months and below 5% in children between 3 and 12 months.; The insufficient amount of sweat rates will be compared between the two methods.

Trial Locations

Locations (1)

Cliniques Universitaires St Luc; 🇧🇪 Brussels, Belgium