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

NCT03913507 | Completed

• 1 other identifier: 2018/14JUI/253
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Keywords

Cystic Fibrosis Children

Outcome Measures

Primary Outcomes (1)

• chloride concentration

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

  day 1

Secondary Outcomes (1)

• sweat

  day 1

Study Arms (1)

one group : patients with suspicion of cystic fibrosis

EXPERIMENTAL

Device: Macroduct® Advanced Model 3710 SYS, Wescor

Interventions

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.

one group : patients with suspicion of cystic fibrosis

Eligibility Criteria

• Age: 2 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Subjects weighing less than 2 kg
• Subjects less than 48 hours old
• Presence of an acute infectious condition
• Presence of mineralocorticoid treatment

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Teresinha Leal

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: April 12, 2019
• Study Start: July 14, 2018
• Primary Completion: December 31, 2020
• Study Completion: March 22, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

BE (1)