NCT06852053 · University of Alabama at Birmingham
Application to Predict Neonatal Apnea With Bradycardia
(APNeA)
What this study is about
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
View original scientific description
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
Interventions
DEVICE
Closed-loop Vibro-Tactile Stimulator
Vibro-Tactile stimulation when bradycardia is predicted or predicted.
DEVICE
Control
Sham closed-loop vibrotactile stimulator
Primary outcome measures
Bradycardia <100 beats per minute ≥ 10 seconds
Time frame: 4-hours on either intervention.
The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations