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

NCT ID: NCT03913507

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-14
• Study Completion Date: 2021-03-22

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

one group : patients with suspicion of cystic fibrosis

Group Type: EXPERIMENTAL

Macroduct® Advanced Model 3710 SYS, Wescor

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teresinha Leal

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques Universitaires St Luc

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2018/14JUI/253

Identifier Type: -

Identifier Source: org_study_id