Recruiting

SVS with Caffeine

Sponsor:

Tufts Medical Center

Code:

NCT06374147

Conditions

Apnea of Prematurity

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

SVS mattress

Study Details

Brief summary:

The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay.

Conditions

Apnea of Prematurity

Study ID

NCT06374147

Start date

Feb 6, 2025

Status verified date

Feb, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 22 week 0 days-32 weeks 6 days gestational age (preterm)
  • Either sex
  • Single birth
  • At least 4 clinically documented apnea events in the previous 24 hours
  • Caffeine citrate at least 5 mg/kg/day dosing, with or without respiratory support oxygen, nasal cannula, or CPAP without and added rate or pressure support, if considered necessary by the clinical team)

Exclusion Criteria:

  • Intubation and mechanical ventilation, or non-invasive positive pressure ventilation (NIPPV) if not intubated, or pressure support breaths while on CPAP.
  • Refusal or withdrawal of consent
  • Major congenital malformations (not including patent ductus arteriosus, small hernia)
  • Known disorder of breathing other than apnea of prematurity (e.g., congenital central hypoventilation syndrome, laryngotracheomalacia)
  • Caffeine citrate dosing exceeding FDA recommended dosing in the first 24 hours, if deemed necessary by the clinical team

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SVS mattress arm

The intervention group will receive standard therapy ( Caffeine Citrate) plus continuous SVS stimulation using the Prapela SVS incubator pad. 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.

no intervention: Standard

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

Interventions

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

Primary outcome measure

  • Change in apnea rate [ Time Frame: 7-28 days of intervention ]

Central Contacts and Locations

Central contacts

Rachana Singh, MD, MS

6176365322rachana.singh1@tuftsmedicine.org

John Konsin

8337727352johnkonsin@prapela.com

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Namasivayam Ambalavanan, MD

800-822-8816nambalav@uabmc.edu

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Rachana Singh, MD MS

617-636-5322rachana.singh1@tuftsmedicine.org

More Information

Sponsor

Tufts Medical Center

Last update posted

Mar 7, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts Medical Center on 2025-03-07.