Owlet pulse oximeter monitoring after NICU discharge to reduce ER visits and rehospitalizations
Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER): A Randomized Clinical Trial
This trial tests whether giving infants discharged from the NICU an Owlet OSS 3.0 pulse oximeter for six months can reduce emergency room visits and high-acuity rehospitalizations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 22 Weeks to 6 Months |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06565390 on ClinicalTrials.gov |
What this trial studies
This is a randomized trial enrolling infants being discharged from the NICU who are off all respiratory support and do not have a home cardiorespiratory monitor. Participants are randomly assigned to receive an Owlet OSS 3.0 pulse oximeter for remote monitoring for six months or to receive routine care. Investigators will collect monthly outcome measures from caregivers and compare rates of emergency department visits and high-acuity rehospitalizations between groups. The trial excludes infants with major malformations, neuromuscular respiratory disorders, complex congenital heart disease with hemodynamic shunts, or terminal illness.
Who should consider this trial
Good fit: Ideal candidates are infants being discharged from the NICU who are off all respiratory support, born at ≥22 0/7 weeks' gestation, without excluded major conditions, and whose parents consent to enrollment.
Not a fit: Infants discharged with a home cardiorespiratory monitor, those still on respiratory support, or those with major congenital or terminal conditions are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, remote pulse oximeter monitoring could lower emergency department visits and serious rehospitalizations after NICU discharge by enabling earlier detection of low oxygen levels at home.
How similar studies have performed: Prior evidence on home pulse oximetry in post-discharge infants is limited and mixed, with few randomized trials showing consistent reductions in rehospitalization.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Colm P Travers, M.D. — University of Alabama at Birmingham
- Study coordinator: Kimberly Armstead, BS
- Email: karmstead@uabmc.edu
- Phone: 205-934-0095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.