NPD Measurement in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00564304
Recruitment Status : Unknown
Verified November 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2007
Last Update Posted : November 27, 2007
Information provided by:
Hadassah Medical Organization

Brief Summary:

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 or disease
Cystic Fibrosis

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nasal Potential Difference Measurement in Infants
Study Start Date : March 2008
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
children below age of 6 years who suspected for Cystic Fibrosis

Inclusion Criteria:

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

Exclusion Criteria:

  • Age over 6 years

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 identifier (NCT number): NCT00564304

Contact: Arik Tzukert, DMD 972-2-6776095
Contact: Hadas Lemberg, PhD 972-2-6777572

Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Michael Wilschanski, Dr. Hadassah Medical Organization Identifier: NCT00564304     History of Changes
Other Study ID Numbers: will004-HMO-CTIL
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2007

Keywords provided by Hadassah Medical Organization:
Nasal Potential Difference

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