Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates

Part of paid clinical trials in Palo Alto, California.

Sponsor
Neola Medical Inc
Study ID
NCT07060911
Status
Not Yet Recruiting

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Conditions

  • Lung Diseases
  • Preterm Birth
  • RDS of Prematurity

Eligibility Criteria

Sex
ALL
Age
1 Day - 44 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Lung monitoring with the Neola device — DEVICE
    Lung monitoring with the Neola device

Study Details

Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates

Key Dates

Start date
Mar 31, 2026
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Arm 1
    Lung monitoring with the Neola device

Primary Outcome Measure

The number of device related events including skin reactions [ Time Frame: 2 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford Lucile Packard Children's Hospital Neonatal Intensive Care UnitPalo AltoCalifornia94304
Valerie Chock, M.D., M.S. Epi
[email protected]
(650) 497-8800
Valerie Chock, M.D., M.S. Epi (PRINCIPAL_INVESTIGATOR)
Cooper Health SystemCamdenNew Jersey08103
Vineet Bhandari, MD, DM
[email protected]
856-342-2000
Vineet Bhandari, MD, DM (PRINCIPAL_INVESTIGATOR)

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Stanford Lucile Packard Children's Hospital Neonatal Intensive Care Unit· Palo Alto, CACooper Health System· Camden, NJ

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