CO2 Detector for Neonatal Resuscitation

(CO2-Vent Trial)

This trial aims to determine if a device called Pedi-Cap can assist newborns needing breathing support immediately after birth. The Pedi-Cap, a color-changing tool, helps doctors and nurses check if a baby is exhaling carbon dioxide properly, potentially reducing the time the baby requires breathing assistance. Some newborns will receive care with the Pedi-Cap, while others will not, to compare outcomes. Babies born at or after 30 weeks who need breathing support are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance newborn care.

The trial does not specify whether participants need to stop taking their current medications.

Research has shown that CO2 detectors, such as the Pedi-Cap, are safely used in newborns during resuscitation. These devices help ensure correct placement of breathing tubes by changing color with each breath, allowing the medical team to monitor the baby's breathing. Studies have found that using these detectors can reduce complications in infants, particularly those at risk of changes in blood flow to the brain. This indicates that the Pedi-Cap is generally well-tolerated in newborns, with no major safety concerns reported.¹²³⁴⁵

Researchers are excited about the Pedi-Cap because it introduces an innovative way to assess effective neonatal resuscitation by using color change to indicate carbon dioxide (CO2) exchange. Unlike standard methods that rely solely on monitoring heart rate, infant color, chest rise, and oxygen saturation, the Pedi-Cap provides immediate visual confirmation of effective ventilation through a simple color shift from purple to gold with each exhalation. This real-time feedback can help the resuscitation team quickly determine if a newborn is receiving adequate non-invasive positive pressure ventilation (PPV), potentially improving response times and outcomes in critical delivery room situations.

In this trial, some participants will use the Pedi-Cap, a device that changes color, during newborn resuscitation. Studies have shown that the Pedi-Cap turns gold before a baby's heart rate significantly increases, confirming that the baby receives enough air. This helps the resuscitation team determine if they provide sufficient air to the baby. Additionally, it has proven effective in confirming the correct placement of breathing tubes in newborns. The Pedi-Cap offers immediate feedback, leading to faster and more accurate resuscitation efforts.¹³⁴⁶⁷