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NCT06693817: AWARD
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
NA trial testing Wireless skin sensors vital sign monitoring system in Sudden Unexplained Infant Death in 600 participants. Currently enrolling.
30 July 2026
Quick facts
| Lead sponsor | Guilherme Sant'Anna, MD |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 600 |
| Start date | 8 April 2025 |
| Primary completion | 30 July 2026 |
| Estimated completion | 30 June 2027 |
| Sites | 7 locations across Zimbabwe, Argentina, Canada, Mozambique, Brazil |
Drugs / interventions tested
- Wireless skin sensors vital sign monitoring system
- Wired vital sign monitoring system
Conditions studied
- Sudden Unexplained Infant Death — all drugs for Sudden Unexplained Infant Death →
- Apnea of Newborn — all drugs for Apnea of Newborn →
- Newborn Morbidity — all drugs for Newborn Morbidity →
- Newborn Asphyxia — all drugs for Newborn Asphyxia →
Sponsor
Guilherme Sant'Anna, MD
Who can join
Adults 35 Weeks to 42 Weeks, any sex, with Sudden Unexplained Infant Death or Apnea of Newborn. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to: 1. Assess feasibility 2. Evaluate safety 3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06693817
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sudden Unexplained Infant Death
Currently open trials in the same condition.
- NCT05503771 — Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record · NA · recruiting
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 NCT06693817 (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 Guilherme Sant'Anna, MD
- Last refreshed: 17 April 2025
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/NCT06693817.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing