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Advanced Wireless Sensors for Neonatal Care in the Delivery Room

Study acronym: AWARD
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Jul 30, 2026 to Jul 30, 2027
    • Study sites: 7 to 5
    • Study completion date: Jun 30, 2027 to Dec 30, 2027
    • Collaborators: 5 to 3
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2025 to Apr 8, 2025
    • Site details revised at 7 of 7 sites
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Primary endpoints revised (14)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06693817
Lead Sponsor Guilherme Sant'Anna, MD
Collaborators: Hospital Universitário da Universidade Estadual de Londrina, Nuovo Ospedale degli Infermi, Luzerner Kantonsspital
Conditions
(from sponsor)		 Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia, Birth Outcome, Adverse, Birth Asphyxia, Pregnancy Related, Newborn; Vitality +9 more
Related terms Asphyxia Neonatorum, Infant Death, Infant, Newborn, Diseases, Pregnancy Complications
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov