Recruiting

Owlet OSS 3.0

Sponsor:

University of Alabama at Birmingham

Code:

NCT06565390

Conditions

Emergencies

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Babies in the Owlet monitor group

Study Details

Brief summary:

This randomized clinical trial will determine the efficacy of remote patient monitoring using an Owlet OSS 3.0 pulse oximeter for the reduction of emergency room visits and high-acuity rehospitalizations among high-risk infants after NICU discharge.

Conditions

Emergencies

Study ID

NCT06565390

Start date

Sep 11, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Infants being discharged from the NICU
  • Off all respiratory support (oxygen, CPAP, ventilator) before discharge home
  • Gestational age ≥ 22 0/7 weeks' gestation at birth
  • Parents/legal guardians have provided consent for enrollment

Exclusion Criteria:

  • a major malformation, a neuromuscular condition that affects respiration or causes apnea, complex congenital heart disease and hemodynamically significant shunts, or terminal illness or decision to withhold or limit support.
  • Infants being discharged from the neonatal intensive care unit (NICU) with a cardiorespiratory monitor or respiratory support are not eligible for inclusion.

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Babies in the Owlet monitor group

The Owlet group will be given an Owlet OSS 3.0 monitor to wear when sleeping. The Owlet alarms if the baby has a very low heart rate or very low oxygen levels. In addition, caregivers in the Owlet group with a smart phone and Wi-Fi access will be able to use an application to monitor the baby's vital signs and sleep state. Will complete a survey or questionnaire every month until 6 months after discharge.

no intervention: Babies in the Usual Care Group

The usual care group will not be given an Owlet vital sign monitor. Will complete a survey or questionnaire every month until 6 months after discharge.

Interventions

Babies in the Owlet monitor group

The Owlet group will be given an Owlet OSS 3.0 monitor to wear when sleeping. The Owlet alarms if the baby has a very low heart rate or very low oxygen levels. In addition, caregivers in the Owlet group with a smart phone and Wi-Fi access will be able to use an application to monitor the baby's vital signs and sleep state.

Primary outcome measure

  • Emergency room visits and high-acuity rehospitalizations. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Kimberly Armstead, BS

205-934-0095karmstead@uabmc.edu

Rachel Benz, MSN

205-934-4680rbenz@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Colm Travers, MD

2053545008colmtravers@hotmail.com

Kimberly Armstead, BS

karmstead@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-09-30.