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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Eligibility

Sex: ALLMin age: 2 DaysMax age: 12 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

chloride concentration

The volume and the chloride concentration will be analyzed for each subject.

Time frame: day 1

Secondary Outcomes

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.