Application to Predict Neonatal Apnea With Bradycardia

NCT06852053 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 300008477UAB
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea Neonatal; Bradycardia Neonatal

Outcome Measures

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.

  4-hours on either intervention.

Secondary Outcomes (15)

• Bradycardia <60 beats per minute ≥ 5 seconds

  4 hours in either intervention.

• Bradycardia <60 beats per minute ≥ 10 seconds

  4 hours on either intervention.

• Bradycardia <80 beats per minute ≥ 5 seconds

  4 hours on either intervention.

• Bradycardia <80 beats per minute ≥ 10 seconds

  4 hours on either intervention.

• Proportion of time with Bradycardia < 100 beats per minute

  4 hours on either intervention.

Study Arms (2)

Virbrotactile stimulation

EXPERIMENTAL

Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected.

Device: Closed-loop Vibro-Tactile Stimulator

Control

SHAM COMPARATOR

Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected.

Device: Control

Interventions

Closed-loop Vibro-Tactile Stimulator DEVICE

Vibro-Tactile stimulation when bradycardia is predicted or predicted.

Virbrotactile stimulation

Control DEVICE

Sham closed-loop vibrotactile stimulator

Control

Eligibility Criteria

• Age: 22 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

Location

Study Officials

• Colm P. Travers Associate Professor of Pediatrics, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel L. Benz, Clinical Research Nurse Manager, MSN

CONTACT

205-934-2184; rlbenz@uabmc.edu

Kimberly M. Armstead Clinical Research Coordinator III, B.S.

CONTACT

205-934-0095; karmstead@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)