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

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ClinicalTrials.gov Identifier: NCT03913507
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Macroduct® Advanced Model 3710 SYS, Wescor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis
Actual Study Start Date : July 14, 2018
Estimated Primary Completion Date : July 14, 2020
Estimated Study Completion Date : July 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: one group : patients with suspicion of cystic fibrosis 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.




Primary Outcome Measures :
  1. chloride concentration [ Time Frame: day 1 ]
    The volume and the chloride concentration will be analyzed for each subject.


Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913507


Contacts
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Contact: Teresinha Teresinha 00 32 2 764 9473 ext 9473 teresinha.leal@uclouvain.be
Contact: Audrey REYNAERTS 00 32 2 764 9472 ext 9472 audrey.reynaerts@uclouvain.be

Locations
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Belgium
Cliniques Universitaires St Luc Recruiting
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Teresinha Leal Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03913507     History of Changes
Other Study ID Numbers: 2018/14JUI/253
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Cystic Fibrosis Children
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases