"Prapela® SVS Incubator Pad for Apnea of Prematurity"

NARecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

February 6, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

December 31, 2026

Conditions
Apnea of Prematurity
Interventions
DEVICE

SVS mattress

The intervention group will receive standard therapy plus continuous SVS stimulation using the Prapela SVS incubator pad. The control group will receive only standard therapy, using an inert pad (identical to the SVS pad, its controller, and green light, but without the transducer and therefore incapable of vibration), in order to mask caregivers. Treatment with the pad will continue until an infant is apnea-free for 3 days and \<2 weeks from anticipated discharge or at the clinician's discretion to discontinue treatment. After ending treatment, clinicians will observe patients 24 hours later and if apnea returns, should re-initiate treatment as needed. At 1 and 2 years of age, parents will be contacted for a brief telephone follow up survey to assess neurological development

Trial Locations (2)

35233

RECRUITING

University of Alabama, Birmingham

02111

RECRUITING

Tufts Medical Center, Boston

All Listed Sponsors
collaborator

University of Alabama at Birmingham

OTHER

lead

Tufts Medical Center

OTHER