140
Participants
Start Date
February 6, 2025
Primary Completion Date
October 1, 2026
Study Completion Date
December 31, 2026
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
RECRUITING
University of Alabama, Birmingham
RECRUITING
Tufts Medical Center, Boston
University of Alabama at Birmingham
OTHER
Tufts Medical Center
OTHER