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임상시험 NCT07485907 (OVNI3)은(는) 세기관지염에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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National Observatory of Children Hospitalized With Bronchiolitis (OVNI3) 1,000

대상자모집전
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07485907 (OVNI3)은(는) 세기관지염에 대해 알아보는 관찰연구입니다. 현재 상태는 대상자모집전이며, 2026년 3월 15일부터 참여 신청이 가능합니다. 1,000명의 참여자를 모집할 예정입니다. Association Clinique Thérapeutique Infantile du val de Marne이(가) 진행하는 이 연구는 2027년 3월 15일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 20일에 갱신되었습니다.
간단한 개요
OVNI3 is multicenter, non-interventional study based on the analysis of retrospective patient data extracted from medical records and collected as part of routine clinical care following hospitalization for bronchiolitis
상세한 설명
Patients will be identified at each participating center if a diagnosis of bronchiolitis meeting the study inclusion criteria is documented in the medical record.

As this is a retrospective study based exclusively on previously collected health data (for hospitalization occurring between October 15, 2025, and February 15, 2026), and involving no additional procedures or modification of patient management, inclusion ...

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공식 제목

National Observatory of Children Hospitalized With Bronchiolitis

질환명
세기관지염
기타 연구 식별자
  • OVNI3
NCT 번호
NCT07485907
실제 연구 시작일
2026-03-15
최신 업데이트 게시
2026-03-20
예상 연구 완료일
2027-03-15
계획된 등록 인원
1,000
연구종류
관찰연구
상태
대상자모집전
시험군 / 개입
참가자 그룹/시험군개입/치료
Children hospitalized for bronchiolitis
collected data of all children, under 12 months of age, hospitalized for bronchiolitis from the October 15, 2025 to February 15, 2026
해당 없음
주요결과변수
결과변수측정값 설명시간 범위
Evaluate the nirsevimab effectiveness for RSV Bronchiolitis hospitalized vs Non-RSV Bronchiolitis in 2025/2026.
This outcome evaluates the effectiveness of nirsevimab in preventing hospitalizations for RSV bronchiolitis among infants under 12 months of age during the 2025/2026 season. Effectiveness is assessed by comparing the number of hospitalizations for RSV bronchiolitis in infants who received nirsevimab versus those who did not.
6 months
이차결과변수
결과변수측정값 설명시간 범위
Difference of effectiveness during the 2 seasons (2024/2025 vs 2025/2026)
This outcome evaluates the difference in nirsevimab effectiveness by comparing the number of hospitalizations for RSV bronchiolitis among infants immunized with nirsevimab during the 2024/2025 and 2025/2026 seasons. The comparison allows assessment of potential changes in effectiveness across the two consecutive RSV seasons.
2 years
Hospitalization Proportions according to Nirsevimab and RSV Status, based on different age Groups
This outcome evaluates the proportion of infants under 12 months hospitalized for bronchiolitis according to their Nirsevimab immunization status and RSV infection status. Analyses are stratified by age groups: under 3 months, 3-6 months, and 6-12 months, to assess variations in hospitalization risk and Nirsevimab effectiveness across age categories.
6 months
Proportion of hospitalizations for bronchiolitis associated with other viruses (isolated or associated with RSV)
This outcome evaluates the proportion of hospitalizations for bronchiolitis in infants under 12 months that are associated with viruses other than RSV, either as isolated infections or in co-infection with RSV. The analysis aims to describe the burden of non-RSV viral bronchiolitis and its interaction with RSV infections.
6 months
참여 도우미
적격성 기준

연령대
어린이
최소 연령
1 Day
참여 가능한 성별
전체
  • Children under 12 months
  • Treated at one of the 12 study sites
  • From October 15, 2025 to February 15, 2026
  • For acute bronchiolitis defined according to current national and international recommendations
  • Hospitalized

and

  • RSV testing
  • Known nirsevimab immunization status for the ongoing 2025/2026 season

  • Refusal to participate by the legal representative
  • Maternal immunization with abrysvo after September 1st 2025
Association Clinique Thérapeutique Infantile du val de Marne logoAssociation Clinique Thérapeutique Infantile du val de Marne
GPIP : Groupe de Pathologies Infectieuses Pédiatriques, membre de la Société Française de Pédiatrie logoGPIP : Groupe de Pathologies Infectieuses Pédiatriques, membre de la Société Française de Pédiatrie
연구 대표 연락처
연락처: Corinne Levy, 1 48 85 04 04, [email protected]
연락처: Stéphane Béchet, 1 48 85 96 68, [email protected]
1 1개국에 임상시험 장소
ACTIV, Créteil, 94000, France
Corinne Levy, 연락처, 148850404, [email protected]
Stéphane Béchet, 연락처, 1 48 85 96 68, [email protected]