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NCT04182555
Identification of Jaundice in Newborns Using Smartphones
NA trial testing Bilirubin estimates from Smartphone Application in Jaundice, Neonatal in 220 participants. Completed in 15 September 2020.
15 September 2020
Quick facts
| Lead sponsor | St. Olavs Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 220 |
| Start date | 3 August 2020 |
| Primary completion | 15 September 2020 |
| Estimated completion | 15 September 2020 |
| Sites | 2 locations across Norway |
Drugs / interventions tested
- Bilirubin estimates from Smartphone Application
- Bilirubin concentration measured in standard blood samples
- Bilirubin estimates from standard transcutaneous device
- Visual assessment of jaundice
Conditions studied
- Jaundice, Neonatal — all drugs for Jaundice, Neonatal →
- Hyperbilirubinemia, Neonatal — all drugs for Hyperbilirubinemia, Neonatal →
Sponsor
St. Olavs Hospital
Who can join
Adults 1 Day to 14 Days, any sex, with Jaundice, Neonatal or Hyperbilirubinemia, Neonatal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Neonatal jaundice is a common and most often harmless condition. However, when unrecognized it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease is therefore to identify then children at risk. This results in the need for low-cost, reliable and easy-to-use diagnostic tools that can identify newborns with jaundice. Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a smartphone application was developed and tested in a pilot study and the application refined. This smartphone application will now be evaluated in a clinical trial set in two hospitals in Norway. The smartphone application gives immediate estimates of bilirubin values in newborns, and these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study.
Aune A, Vartdal G, Jimenez Diaz G, Gierman LM, et al · · 2023 · cited 12× · PMID 36853753 · DOI 10.2196/40463
Verify or expand the search:
- PubMed search for NCT04182555
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Jaundice, Neonatal
Currently open trials in the same condition.
- NCT06687746 — Evaluation of Bili-ruler, a Low-cost, Plastic Icterometer for Community-based Screening of Jaundice in Newborns · active not recruiting
- NCT03866213 — Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings · recruiting
Other St. Olavs Hospital trials
Trials by the same sponsor.
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- NCT07180433 — Piloting 18F-FAPI PET/MRI for Applications in Breast Cancer · NA · not yet recruiting
- NCT06854861 — Premixed Glucagon/Insulin Solution for Faster Insulin Absorption in Type 1 Diabetes · Phase 1, PHASE2 · suspended
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 NCT04182555 (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 St. Olavs Hospital
- Last refreshed: 26 September 2022
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/NCT04182555.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing