"Prapela® SVS Incubator Pad for Apnea of Prematurity

Launched by TUFTS MEDICAL CENTER · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of incubator pad called the Prapela® SVS Pad, designed to help preterm infants who experience a condition known as apnea of prematurity (AOP). AOP is when premature babies have pauses in their breathing. The trial aims to see if this special pad, which uses gentle vibrations to stimulate the baby, can safely improve breathing in these infants. Currently, the only approved treatment for AOP is caffeine, and this new pad could potentially reduce the need for breathing support and help babies leave the hospital sooner.

To participate in the trial, babies must be born between 22 and 32 weeks of gestation and have experienced at least four episodes of apnea in the last day. They should also be receiving caffeine treatment. However, babies who are on more intensive breathing support, have major birth defects, or have other serious breathing disorders are not eligible. If your baby qualifies, they will be monitored closely while using the SVS pad to see how it affects their breathing and overall health during their stay in the hospital.

Gender

ALL

Eligibility criteria

• 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