Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis (MACRODUCT-3710)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: Macroduct® Advanced Model 3710 SYS, Wescor

Study type: Interventional

Funder types: Other

Identifiers

NCT03913507

2018/14JUI/253

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 2 days to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

one group : patients with suspicion of cystic fibrosis

Experimental group

Treatment:

Device: Macroduct® Advanced Model 3710 SYS, Wescor