Application to Predict Neonatal Apnea With Bradycardia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-32
SponsorUniversity of Alabama at Birmingham
About this trial
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
Eligibility criteria
Qualifiers
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
Disqualifiers
a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
Trial design
Treatments tested in this trial
- Closed-loop Vibro-Tactile Stimulator
- Control
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov