RECRUITING

"Prapela® SVS Incubator Pad for Apnea of Prematurity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

"Prapela® SVS Incubator Pad: a Cost-effective Stochastic Vibrotactile Device to Improve the Clinical Course of Infants with Apnea of Prematurity."

Quick Facts

Study Start:2025-02-06
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06374147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Days to 3 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 22 week 0 days-32 weeks 6 days gestational age (preterm)
  2. * Either sex
  3. * Single birth
  4. * At least 4 clinically documented apnea events in the previous 24 hours
  5. * 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)
  1. * Intubation and mechanical ventilation, or non-invasive positive pressure ventilation (NIPPV) if not intubated, or pressure support breaths while on CPAP.
  2. * Refusal or withdrawal of consent
  3. * Major congenital malformations (not including patent ductus arteriosus, small hernia)
  4. * Known disorder of breathing other than apnea of prematurity (e.g., congenital central hypoventilation syndrome, laryngotracheomalacia)
  5. * Caffeine citrate dosing exceeding FDA recommended dosing in the first 24 hours, if deemed necessary by the clinical team

Contacts and Locations

Study Contact

Rachana Singh, MD, MS
CONTACT
6176365322
rachana.singh1@tuftsmedicine.org
John Konsin
CONTACT
8337727352
johnkonsin@prapela.com

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35233
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States

Collaborators and Investigators

Sponsor: Tufts Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-02-06
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Apnea of Prematurity