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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

2 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macroduct® Advanced Model 3710 SYS, Wescor

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.

Primary outcomes

chloride concentration

Time frame: day 1

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

Secondary outcomes

sweat

Time frame: day 1

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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: MACRODUCT-3710

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Apr 12, 2019
Registry last updated: Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed