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NCT02302183: Infant-Free02
Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2)
NA trial testing FreeO2 v2.0 automatic adjustment in Hypoxemic Acute Respiratory Distress in 60 participants. Completed in 23 February 2017.
23 February 2017
Quick facts
| Lead sponsor | University Hospital, Brest |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 24 December 2014 |
| Primary completion | 23 February 2017 |
| Estimated completion | 23 February 2017 |
| Sites | 1 location across France |
Drugs / interventions tested
- FreeO2 v2.0 automatic adjustment
- FreeO2 v2.0 data collecting
Conditions studied
- Hypoxemic Acute Respiratory Distress — all drugs for Hypoxemic Acute Respiratory Distress →
- Infant Between 1 Month and 24 Months Old — all drugs for Infant Between 1 Month and 24 Months Old →
- Child Between 2 and 15 Years Old — all drugs for Child Between 2 and 15 Years Old →
Sponsor
University Hospital, Brest
Who can join
Adults 1 Month to 15, any sex, with Hypoxemic Acute Respiratory Distress or Infant Between 1 Month and 24 Months Old. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress. In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Automated oxygen delivery for preterm infants with respiratory dysfunction.
Stafford IG, Lai NM, Tan K. · · 2023 · cited 13× · PMID 38032241 · DOI 10.1002/14651858.cd013294.pub2
Verify or expand the search:
- PubMed search for NCT02302183
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02302183 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Brest
- Last refreshed: 3 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02302183.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing