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

Cystic Fibrosis Clinical Trial

— MACRODUCT-3710  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913507
• Other study ID #: 2018/14JUI/253
• Status: Completed
• Phase: N/A
• Start date: July 14, 2018
• Est. completion date: March 22, 2021

Study information

• Verified date: March 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 22, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chloride concentration	The volume and the chloride concentration will be analyzed for each subject.	day 1
Secondary	sweat	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.	day 1