Application to Predict Neonatal Apnea With Bradycardia
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Closed-loop Vibro-Tactile Stimulator
DeviceVibro-Tactile stimulation when bradycardia is predicted or predicted.
Control
DeviceSham closed-loop vibrotactile stimulator
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Virbrotactile stimulationExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bradycardia <100 beats per minute ≥ 10 seconds
The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period.
Time frame
4-hours on either intervention.Secondary outcomes
1
Bradycardia <60 beats per minute ≥ 5 seconds
The frequency of episodes of bradycardia (heart rate \<60 beats per minute ≥ 5 seconds) in either study arm during the study period.
Time frame
4 hours in either intervention.2
Bradycardia <60 beats per minute ≥ 10 seconds
The frequency of episodes of bradycardia (heart rate \<60 beats per minute ≥ 10 seconds) in either study arm during the study period.
Time frame
4 hours on either intervention.3
Bradycardia <80 beats per minute ≥ 5 seconds
The frequency of episodes of bradycardia (heart rate \<80 beats per minute ≥ 5 seconds) in either study arm during the study period.
Time frame
4 hours on either intervention.4
Bradycardia <80 beats per minute ≥ 10 seconds
The frequency of episodes of bradycardia (heart rate \<80 beats per minute ≥ 10 seconds) in either study arm during the study period.
Time frame
4 hours on either intervention.Sponsors and contacts
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Source ClinicalTrials.gov