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NCT04811248: WheezOut
Respiratory Outcome of Infants With or Without Documented Wheezing During Bronchiolitis
trial testing telephone call for parents of patients in Wheezing in 281 participants. Status unknown.
8 January 2024
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 281 |
| Start date | 8 January 2021 |
| Primary completion | 8 January 2024 |
| Estimated completion | 8 January 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- telephone call for parents of patients
Conditions studied
- Wheezing — all drugs for Wheezing →
- Asthma in Children — all drugs for Asthma in Children →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 3 to 7, any sex, with Wheezing or Asthma in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hospital admission for infant bronchiolitis is associated with an increased risk of recurrent wheezing and subsequent asthma in childhood. In the literature, 17 to 60% of children will develop repeated wheezing (infant asthma in France). This highly variable incidence could be linked in part to the fact that the definition of bronchiolitis varies between continents. In Europe the usual definition is an acute and contagious viral infection which affects the bronchioles (small bronchi) of infants accompanied by coughing, rapid breathing and wheezing. In research studies, bronchiolitis must be associated with wheezing and / or crackles on auscultation in Europe, and wheezing imperatively in the USA. The diagnosis of wheezing is difficult, and medical agreement on auscultatory respiratory abnormalities is poor. We thus have developed a wheezing diagnostic tool using artificial intelligence processing of respiratory sound recordings by smartphone (Bokov P, Comput Biol Med 2016, DOI: 10.1016/j.compbiomed.2016.01.002). In a second larger bicentric study that included only infants suspected of bronchiolitis, our approach has consisted in obtaining a recording by smartphone but also by electronic stethoscope in order to allow deferred listening of the sounds (WheezSmart study). The objective of these studies was to obtain a formal diagnosis of wheezing, the current project aims to assess the benefit of this diagnosis. The main objective of this cross-sectional study is to determine whether the formal presence (diagnosis of wheezing from a recording of pulmonary auscultation) is associated with the risk of childhood asthma (diagnosis of asthma at 6 years) regardless of the usual risk factors (atopic / allergic terrain, exposure to smoking, recurrence of symptoms). The secondary objectives are to determine whether the formal presence of wheezing on auscultation is a risk factor for subsequent repeated wheezing (diagnosis of infant asthma) and for initial disease severity (bronchiolitis) compared to SpO2 and admission of the child to hospital. The interest in differentiating between high and low frequency sibilants will be evaluated also.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04811248
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Wheezing
Currently open trials in the same condition.
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- NCT05667701 — Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study · Phase 2 · recruiting
- NCT06603584 — Phenotypes of Preschool Wheezing Among Children Attending Sohag University Hospital · recruiting
- NCT06311162 — Early Life Intervention in Pediatrics Supported by E-health - SMOKE · NA · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04811248 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 18 October 2021
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