An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0

NCT05561946 | Completed

• 1 other identifier: OWL 2021-01
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

This multi-center, open-label, observational study will evaluate possible skin reactions associated with the wearing of the Owlet OSS 3.0 device continuously (except during sensor charging and excessive motion) up to 24 hours per day in a clinical environment.

Conditions

Skin Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinically Important Skin Reactions

  To estimate the incidence of clinically important skin reactions associated with the Owlet Sock OSS 3.0 when instructions for use are followed.

  From baseline to study completion

Secondary Outcomes (3)

• Skin reaction resolution

  From onset of observation of skin finding until end of study participation, up to 30 days.

• Estimate the proportion of skin reactions that require medical intervention.

  During period of study monitoring, approximately 14 days.

• Estimate the incidence of any skin reactions, overall and by severity level.

  From initiation of study intervention to end of study intervention, approximately 14 days.

Study Arms (2)

Hospitalized Infants

Hospitalized infants that are planned/scheduled to remain in-house for at least 2 days will wear the sock for a minimum of 48 hours and a maximum of 14 days.

Device: Owlet OSS 3.0

Healthy Infants

Healthy infants, accompanied by their parent or legal guardian, that are able to stay at a clinical site for 2 days to complete a minimum of 48 hours of monitoring.

Device: Owlet OSS 3.0

Interventions

Owlet OSS 3.0 DEVICE

The Owlet OSS 3.0 is worn continuously for a minimum of 48 hours and the skin where the device is worn is monitored for any skin injury/irritation

Healthy Infants; Hospitalized Infants

Eligibility Criteria

• Age: 44 Weeks - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants admitted for care and estimated to be in the hospital ward/unit, and healthy infants able to stay at a clinical site with study team oversight for at least 48 hours.

You may qualify if:

• Provision of signed and dated informed consent form by the legal guardian
• Stated willingness of the guardian to adhere to study procedures and availability for the duration of the study
• Anticipated to maintain continuity of study procedures under study team oversight for a minimum of 48 hours duration
• Male or female infants aged 1 month (44 weeks corrected gestational age) to 18 months, with weight between 5 and 30 lbs who will be observed in a hospital pediatric department, or other clinical site

You may not qualify if:

• Medical conditions determined by the study subject's physician or site investigator that would prevent their participation
• Presence of any devices or medical equipment that in the opinion of the investigator would interfere with the function of the Owlet device or preclude completion of the protocol
• Patients on vasoactive medications
• Known allergic reactions to nylon, spandex, elastine or polyester film components of the device that will come into contact with skin
• Local skin disease prohibiting wearing of the device

Sponsors & Collaborators

• Owlet Baby Care, Inc.: lead
• Louisiana State University Health Sciences Center Shreveport: collaborator
• University of Utah: collaborator
• Topaz Clinical Research: collaborator

Study Sites (2)

TOPAZ Clinical Research

Apopka, Florida, 32703, United States

Location

Louisiana State University Health Shreveport

Shreveport, Louisiana, 71130, United States

Location

Related Publications (3)

• World Health Organization. MHealth: New Horizons for Health through Mobile Technologies (Global Observatory for Ehealth). 1st ed., World Health Organization, 2011.

  BACKGROUND

• Dangerfield MI, Ward K, Davidson L, Adamian M. Initial Experience and Usage Patterns With the Owlet Smart Sock Monitor in 47,495 Newborns. Glob Pediatr Health. 2017 Dec 4;4:2333794X17742751. doi: 10.1177/2333794X17742751. eCollection 2017.

  PMID: 29230431 BACKGROUND

• Panda SS, Panda M, Das RR, Mohanty PK. Pulse oximeter probe-induced toe injury in a neonate: A rare avoidable injury. J Clin Neonatol 2014;3:240

  BACKGROUND

Study Officials

• Alisa Niksch, MD

  Study Sponsor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 30, 2022
• Study Start: December 21, 2021
• Primary Completion: August 4, 2022
• Study Completion: August 24, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)