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NCT06693817: AWARD

Advanced Wireless Sensors for Neonatal Care in the Delivery Room

Recruiting now NA Last updated 17 April 2025
What this trial tests

NA trial testing Wireless skin sensors vital sign monitoring system in Sudden Unexplained Infant Death in 600 participants. Currently enrolling.

Timeline
8 April 2025
Primary endpoint
30 July 2026
30 June 2027

Quick facts

Lead sponsorGuilherme Sant'Anna, MD
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment600
Start date8 April 2025
Primary completion30 July 2026
Estimated completion30 June 2027
Sites7 locations across Zimbabwe, Argentina, Canada, Mozambique, Brazil

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Sudden Unexplained Infant Death

Currently open trials in the same condition.

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Data sources for this page

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