Application to Predict Neonatal Apnea With Bradycardia

Not Applicable

Not yet recruiting

• Conditions: Apnea Neonatal; Bradycardia Neonatal

• Registration Number: NCT06852053
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Study Start: 2025-10-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bradycardia <100 beats per minute ≥ 10 seconds	4-hours on either intervention.	The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period.

Secondary Outcome Measures

Name	Time	Method
Bradycardia <60 beats per minute ≥ 5 seconds	4 hours in either intervention.	The frequency of episodes of bradycardia (heart rate \<60 beats per minute ≥ 5 seconds) in either study arm during the study period.
Bradycardia <60 beats per minute ≥ 10 seconds	4 hours on either intervention.	The frequency of episodes of bradycardia (heart rate \<60 beats per minute ≥ 10 seconds) in either study arm during the study period.
Bradycardia <80 beats per minute ≥ 5 seconds	4 hours on either intervention.	The frequency of episodes of bradycardia (heart rate \<80 beats per minute ≥ 5 seconds) in either study arm during the study period.
Bradycardia <80 beats per minute ≥ 10 seconds	4 hours on either intervention.	The frequency of episodes of bradycardia (heart rate \<80 beats per minute ≥ 10 seconds) in either study arm during the study period.
Proportion of time with Bradycardia < 100 beats per minute	4 hours on either intervention.	The total proportion of time with bradycardia during the study period on either intervention with a heartrate of \<100 beats per minute.
Hypoxemia <85% for ≥ 5 seconds	4 hours on either intervention.	The frequency of episodes of hypoxemia (oxygen saturations \<85% for ≥ 5 seconds) in either study arm during the study period.
Hypoxemia <85% for ≥ 10 seconds	4 hours on either intervention.	The frequency of episodes of hypoxemia (oxygen saturations \<85% for ≥ 10 seconds) in either study arm during the study period.
Hypoxemia <90% for ≥ 5 seconds	4 hours on either intervention.	The frequency of episodes of hypoxemia (oxygen saturations \<90% for ≥ 5 seconds) in either study arm during the study period.
Hypoxemia <90% for ≥ 10 seconds	4 hours on either intervention.	The frequency of episodes of hypoxemia (oxygen saturations \<90% for ≥ 10 seconds) in either study arm during the study period.
Hypoxemia <80% for ≥ 5 seconds	4 hours on either intervention.	The frequency of episodes of hypoxemia (oxygen saturations \<80% for ≥ 5 seconds) in either study arm during the study period.
Hypoxemia <80% for ≥ 10 seconds	4 hours on either intervention.	The frequency of episodes of hypoxemia (oxygen saturations \<80% for ≥ 10 seconds) in either study arm during the study period.
Proportion of time with hypoxemia < 90%	4 hours on either intervention.	The total proportion of time with oxygen saturations \<90% during the study period on either intervention.
Bradycardia prediction time	4 hours on either intervention.	The number of seconds ahead of routine patient monitors at which the device algorithm predicted bradycardia in either group.
Bradycardia prediction accuracy	4 hours on sham control.	The area under the curve for the true prediction rate over the false alarm rate in the control group.
Proportion of time with hypoxemia < 85%	4 hours on either intervention.	The total proportion of time with oxygen saturations \<85% during the study period on either intervention.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States