NPD Measurement in Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00564304
First received: November 25, 2007
Last updated: November 26, 2007
Last verified: November 2007
  Purpose

Nasal Potential Difference measurements (NPD) have been performed in Israel since 1996. NPD measurements are used to assess the voltage across nasal epithelium, which correlates with the transport of sodium and chloride across cell membranes. NPD was first demonstrated to be abnormal in Cystic Fibrosis (CF) in 1981 and the technique has since been used to increase our understanding of this condition. It is now established as an important diagnostic tool and more recently has been used to assess the effectiveness of new treatments such as gene and alternative therapy (Knowles 1995; Wilschanski 2003).

The nasal cavity is accessible which makes it a good site to examine the ion transport characteristics of airway epithelia. Less than a centimetre into the nose the squamous ("skin type") epithelium becomes ciliated pseudocolumnar epithelium, characteristic of the proximal airways.

The change in NPD with the perfusion of different solutions is demonstrated. By employing NPD protocols with perfusion of different solutions and drugs, different aspects of the nasal ion transport characteristics can be examined. In CF, this ion transport profile is abnormal and the NPD measurement has a number of features that differentiate CF from non-CF. This methodology is well established for measurements in subjects over 6 years of age.

Measurements on smaller children and infants have been very difficult to perform. We propose a new method using smaller, single lumen catheters with much lower perfusion rates (0.2 ml/min compared to up to 5 ml/min with the adult method) .Perfusion measurements will be possible in newly born infants. Obviously this opens up the potential for using NPD as a diagnostic test in babies. This is important as the diagnosis of CF is often difficult to make or refute in babies because of the problems in collecting enough sweat. This may be the ideal diagnostic test for CF in the neonatal nursery in infants with meconium plug syndrome.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nasal Potential Difference Measurement in Infants

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: March 2010
  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

children below age of 6 years who suspected for Cystic Fibrosis

Criteria

Inclusion Criteria:

  • Age below 6 years
  • Patients who suspected for CF due to pulmonary and/or gastrointestinal symptoms

Exclusion Criteria:

  • Age over 6 years
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00564304

Contacts
Contact: Arik Tzukert, DMD 972-2-6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 972-2-6777572 lhadas@hadassah.org.il

Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Michael Wilschanski, Dr. Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00564304     History of Changes
Other Study ID Numbers: will004-HMO-CTIL
Study First Received: November 25, 2007
Last Updated: November 26, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Nasal Potential Difference

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014