Application to Predict Neonatal Apnea With Bradycardia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Closed-loop Vibro-Tactile Stimulator, Control.
- Who it may be relevant to
- Registry conditions: Apnea Neonatal, Bradycardia Neonatal. Basic parameters: 22 Weeks — 32 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Application to Predict Neonatal Apnea With Bradycardia (APNeA Study)
Overview
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.
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.]
Secondary outcome measures (12)
- Bradycardia <60 beats per minute ≥ 5 seconds [Time frame: 4 hours in either intervention.]
- Bradycardia <60 beats per minute ≥ 10 seconds [Time frame: 4 hours on either intervention.]
- Bradycardia <80 beats per minute ≥ 5 seconds [Time frame: 4 hours on either intervention.]
- Bradycardia <80 beats per minute ≥ 10 seconds [Time frame: 4 hours on either intervention.]
- Proportion of time with Bradycardia < 100 beats per minute [Time frame: 4 hours on either intervention.]
- Hypoxemia <85% for ≥ 5 seconds [Time frame: 4 hours on either intervention.]
- Hypoxemia <85% for ≥ 10 seconds [Time frame: 4 hours on either intervention.]
- Hypoxemia <90% for ≥ 5 seconds [Time frame: 4 hours on either intervention.]
- Hypoxemia <90% for ≥ 10 seconds [Time frame: 4 hours on either intervention.]
- Hypoxemia <80% for ≥ 5 seconds [Time frame: 4 hours on either intervention.]
- Hypoxemia <80% for ≥ 10 seconds [Time frame: 4 hours on either intervention.]
- Proportion of time with hypoxemia < 90% [Time frame: 4 hours on either intervention.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT06852053 · 300008477 · UAB