- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03025061
Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma (CERS)
Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma
"Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma" is an observational prospective study in outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), Italy.
The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the level of airway inflammation for different respiratory diseases, especially in children. To date, there are no data on the within-day and the between-day repeatability of the breath pattern in healthy children and in children with moderate asthma.
The breath pattern will be analyzed by collecting, for each child, three samples of the breath through the E-nose. Within-day repeatability will be assessed using two consecutive measurements (the second one after 30 minutes). Between-day repeatability will be assessed using a third measurement repeated after 7 days.
The study is expected to provide information about the accuracy of E-nose measurements for a child population.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Sicily
-
Palermo, Sicily, 이탈리아, 90146
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
A study population of 15 asthmatic children (moderate asthma) attending the outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).
A control group of healthy children (n=30), recruited from the primary schools involved in the municipal project "educational pathways" (Palermo, Italy) to which the PAP group partecipates.
설명
The inclusion criteria for asthmatic children are:
- Moderate asthma (GINA 2015);
- Age 6-11 years;
- No upper airway respiratory infections or exacerbations in the last 4 weeks;
- Steroid-naive asthma;
- Positive bronchodilator response;
- Non smoker.
The inclusion criteria for healthy children are:
- Age 6-11 years;
- No upper airway respiratory infections in the last 4 weeks;
- Non smoker;
- No history of asthma and respiratory diseases during the life;
- Negative bronchodilator response.
The exclusion criteria are:
- Symptoms of acute respiratory infection;
- Immunological and metabolic systemic disease;
- Major malformations of the upper airways;
- Active smoker.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
15 children with moderate asthma
Assessment of E-nose measurements: three E-nose measurements on 15 children with moderate asthma (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days.
These children attend the outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).
|
Breath sampling through E-nose pneumopipe
|
|
30 healthy children
Assessment of E-nose measurements: three E-nose measurements on 30 healthy children (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days.
These children attend the primary schools involved in the municipal project "Educational Pathways" (Palermo).
|
Breath sampling through E-nose pneumopipe
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Electronic nose measurements
기간: 1 week
|
Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.
|
1 week
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Fraction of Exhaled Nitric Oxide (FeNO)
기간: 1 week
|
1 week
|
|
Pulmonary function (FEV1, FVC, etc.)
기간: 1 week
|
1 week
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .