Predicting and stopping breathing pauses in very preterm babies with gentle vibration
Official title: Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)
Run by University of Alabama at Birmingham · NCT06852053 · Data updated 2026-11-12
This study tests a vibro-tactile device to see if it can predict and prevent apnea with bradycardia in preterm infants by briefly stimulating them during episodes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Weeks to 32 Weeks |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Status | Recruiting |
| Started | September 29, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT06852053 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Very preterm infants (<32 weeks gestation) with recent episodes of apnea and bradycardia who are off ventilatory support or on NCPAP for more than 48 hours.
✕Probably not a fit
Certain infants with major congenital abnormalities, neuromuscular conditions affecting respiration, or those with decisions to withhold or limit support may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized cross-over trial, a novel device with extra ECG leads will run an algorithm to predict, detect, and interrupt bradycardia episodes in very preterm babies. Each infant experiences two 4-hour periods: one with vibro-tactile stimulation and one without, separated by a period of no stimulation. The goal is to determine whether the closed-loop stimulator can reduce or stop apneas and bradycardias compared to no stimulation. Participants will be stabilized newborns who previously had apnea with bradycardia and are off certain forms of support. The study is conducted at the University of Alabama at Birmingham with lead sponsorship from UAB.
Why it matters
Potential benefit: If successful, the device could help prevent dangerous breathing pauses in very preterm infants, potentially reducing complications and length of hospital stay.
How similar studies have gone: Prior research in closed-loop stimulation for neonatal respiratory events is limited; this study explores a novel approach in a randomized cross-over design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented episodes of apnea with bradycardia over the previous 24 hours. * Off ventilatory support/NCPAP for \> 48 hours prior to study entry * Gestational age \< 32 0/7 weeks' gestation at birth * Parents/legal guardians have provided consent for enrollment Exclusion Criteria: * a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
Where it's running
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University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting
Study contacts
- Principal investigator: Colm P. Travers Associate Professor of Pediatrics, M.D. — University of Alabama at Birmingham
- Study coordinator: Rachel L. Benz, Clinical Research Nurse Manager, MSN
- Email: rlbenz@uabmc.edu
- Phone: 205-934-2184
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.