Vibro-Tactile Stimulation for Neonatal Apnea
(APNeA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a gentle vibration device called the Closed-loop Vibro-Tactile Stimulator, designed to prevent or reduce breathing pauses and slow heart rates in premature babies. The device activates upon predicting or detecting these episodes, aiming to maintain steady breathing in infants. Babies who have recently experienced breathing pauses with slow heart rates, are not on breathing support, and were born very early (before 32 weeks) might be suitable candidates. As an unphased trial, this study provides families with a unique opportunity to contribute to innovative research that could enhance care for premature infants.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that this device is safe for pre-term infants?
Research has shown that the vibrotactile stimulation system is safe for newborns. Early results from studies indicate that it effectively treats apnea, which are pauses in breathing, without harming the skin or nerves. Another study confirmed these findings, showing that the system can stop apnea episodes with little disturbance to the baby. Overall, the system appears well-tolerated, with no major safety concerns reported.12345
Why are researchers excited about this trial?
Most treatments for neonatal apnea involve medications or respiratory support like continuous positive airway pressure (CPAP) to help keep the baby's airways open. Unlike these standard options, the closed-loop Vibro-Tactile Stimulator offers a non-invasive approach that uses gentle vibrations to stimulate the baby’s skin when an apnea or bradycardia episode is predicted or detected. This method could reduce reliance on more invasive procedures and medications, potentially leading to fewer side effects. Researchers are excited because this innovative approach may provide a more natural way to help newborns regulate their breathing without the need for additional equipment or drugs.
What evidence suggests that this vibro-tactile stimulator is effective for neonatal apnea?
This trial will evaluate the use of a closed-loop Vibro-Tactile Stimulator for neonatal apnea. Research has shown that gentle vibrations can help treat apnea, a condition where newborns stop breathing. Early results from clinical trials suggest that this method can safely wake babies during these breathing pauses. Studies have made the system more portable, allowing use in various settings. Gentle vibrations might offer a safer alternative to traditional methods like tapping to help babies resume normal breathing. This approach has been shown to shorten or even prevent episodes of apnea and slow heart rate. Overall, evidence suggests that gentle vibrations offer a promising way to manage breathing problems in newborns.13456
Who Is on the Research Team?
Colm P. Travers Associate Professor of Pediatrics, M.D.
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for pre-term infants born before 32 weeks' gestation, who've had apnea with a slow heart rate in the last day and are off breathing support for over 48 hours. Parents must consent to join. Infants with major malformations, neuromuscular issues affecting breathing, or terminal illness can't participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo two 4-hour periods: one with vibrotactile stimulation and one without, to assess the algorithm's efficacy in predicting and interrupting bradycardia episodes.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Closed-loop Vibro-Tactile Stimulator
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor