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Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis (MACRODUCT-3710)

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Macroduct® Advanced Model 3710 SYS, Wescor

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis focused on measuring Cystic Fibrosis Children

Eligibility Criteria

2 Days - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques Universitaires St Luc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one group : patients with suspicion of cystic fibrosis

Arm Description

Outcomes

Primary Outcome Measures

chloride concentration

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03913507

First Posted

February 21, 2019

Last Updated

March 23, 2021

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT03913507

Brief Title

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

Acronym

MACRODUCT-3710

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

July 14, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

March 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic Fibrosis Children

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

one group : patients with suspicion of cystic fibrosis

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Macroduct® Advanced Model 3710 SYS, Wescor

Intervention Description

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 Outcome Measure Information:

Title

chloride concentration

Description

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

Time Frame

day 1

Secondary Outcome Measure Information:

Title

sweat

Description

Time Frame

day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Days

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teresinha Leal

Organizational Affiliation

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques Universitaires St Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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