Clinical trial NCT06852053: Application to Predict Neonatal Apnea With Bradycardia
Official title: Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Apnea Neonatal
Bradycardia Neonatal
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.

Detailed description: This will be a randomized cross-over trial that will use additional ECG leads connected to a novel device and laptop to determine the accuracy and efficacy of an algorithm to predict, detect, and interrupt episodes of bradycardia for two 4-hour periods. There will be a 4-hour period without vibro-tactile stimulation and a 4-hour period with vibro-tactile stimulation when episodes are predicted or detected.

Eligibility 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.

Primary outcomes:
measure: Bradycardia <100 beats per minute ≥ 10 seconds
timeFrame: 4-hours on either intervention.
Secondary outcomes:
measure: Bradycardia <60 beats per minute ≥ 5 seconds
timeFrame: 4 hours in either intervention.
measure: Bradycardia <60 beats per minute ≥ 10 seconds
timeFrame: 4 hours on either intervention.
measure: Bradycardia <80 beats per minute ≥ 5 seconds
timeFrame: 4 hours on either intervention.
measure: Bradycardia <80 beats per minute ≥ 10 seconds
timeFrame: 4 hours on either intervention.
measure: Proportion of time with Bradycardia < 100 beats per minute
timeFrame: 4 hours on either intervention.
measure: Hypoxemia <85% for ≥ 5 seconds
timeFrame: 4 hours on either intervention.
measure: Hypoxemia <85% for ≥ 10 seconds
timeFrame: 4 hours on either intervention.
measure: Hypoxemia <90% for ≥ 5 seconds
timeFrame: 4 hours on either intervention.
measure: Hypoxemia <90% for ≥ 10 seconds
timeFrame: 4 hours on either intervention.
measure: Hypoxemia <80% for ≥ 5 seconds
timeFrame: 4 hours on either intervention.
measure: Hypoxemia <80% for ≥ 10 seconds
timeFrame: 4 hours on either intervention.
measure: Proportion of time with hypoxemia < 90%
timeFrame: 4 hours on either intervention.
measure: Bradycardia prediction time
timeFrame: 4 hours on either intervention.
measure: Bradycardia prediction accuracy
timeFrame: 4 hours on sham control.
measure: Proportion of time with hypoxemia < 85%
timeFrame: 4 hours on either intervention.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Colm P. Travers Associate Professor of Pediatrics, M.D.
role: PRINCIPAL_INVESTIGATOR
References: