Cystic FibrosisNCT00564304
NPD Measurement in Infants
An observational study of Cystic Fibrosis, run by Hadassah Medical Organization.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 6 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: children below age of 6 years who suspected for Cystic Fibrosis
Who may be able to join
- Age below 6 years
- Patients who suspected for CF due to pulmonary and/or gastrointestinal symptoms
Who cannot join
- Age over 6 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Nasal Potential Difference Measurement in Infants
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.
Read more
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.
- Conditions
- Cystic Fibrosis
- Keywords
- Nasal Potential Difference
- Medical subject headings
- Cystic Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startMar 2008
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Michael Wilschanski, Dr., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564304
- Sponsor's protocol ID
- will004-HMO-CTIL
- Status last verified
- Nov 2007
- First submitted
- 25 Nov 2007
- Last updated
- 27 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Potential Difference Measurement in Infants
- ClinicalTrials.gov ID
- NCT00564304
- Acronym / sponsor ID
- will004-HMO-CTIL
- Conditions
- Cystic Fibrosis
- Keywords
- Nasal Potential Difference
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2008
- Study completion
- Mar 2010 (estimated)
- First posted
- 27 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children below age of 6 years who suspected for Cystic Fibrosis
Key inclusion criteria (2 listed)
- Age below 6 years
- Patients who suspected for CF due to pulmonary and/or gastrointestinal symptoms
Key exclusion criteria (1 listed)
- Age over 6 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2007.
Related trials for Cystic Fibrosis
Enrolling by invitationObservational study
Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria
Cystic Fibrosis, Nontuberculous Mycobacterial Pulmonary Infection
RecruitingObservational study
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Cystic Fibrosis (CF)
RecruitingObservational study
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Bronchiectasis
Active, not recruitingObservational study
Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease
Cystic Fibrosis, Liver Disease
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wilschanski, Dr. principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arik Tzukert, DMD (972-2-6776095, arik@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2007.