NCT03913507

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 2 Days – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DEVICE	Macroduct® Advanced Model 3710 SYS, Wescor	for each subject, both methods will be tested in order to compare the efficacy of the new sweat collection method (Macroduct® Advanced Model 3710 SYS, Wescor) to the method currently used in clinical routine.

Timeline

• Start date: 2018-07-14
• Primary completion: 2020-12-31
• Completion: 2021-03-22
• First posted: 2019-04-12
• Last updated: 2021-03-24

Locations

1 site across 1 country: Belgium