Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room — CO2-Vent  

Neonatal Disease Clinical Trial

Official title: Randomized Control Trial of Colorimetric CO2 Detectors for Ventilation Assessment in the Delivery Room

Status Recruiting

Clinical Trial Summary

The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed. A group of nurses, doctors, and respiratory therapists, called the neonatal resuscitation team, will either use or not use the Pedi-Cap during face mask PPV for infants born at ≥30 weeks' gestation.

A randomization generator will assign each month either using the Pedi-Cap or not using the Pedi-Cap. The researchers will collect information from the chart to find the infant and mother's information, vital signs, medical interventions done in the delivery room, and lab values. In addition, resuscitation team members will fill out a survey of their experiences of using or not using the Pedi-Cap during delivery room PPV.

Clinical Trial Description

This is an open, prospective, quasi-randomized, single center trial that will address the primary research question: Does use of a colorimetric carbon dioxide (CO2) detector (Pedi-Cap) decrease the duration of non-invasive positive pressure ventilation (PPV) in the delivery room? The neonatal resuscitation team, comprised of nurses, doctors, and respiratory therapists will include or omit the use of Pedi-Cap during noninvasive PPV for infants born at ≥30 weeks' gestation in the delivery room. The quasi-randomization scheme will be determined by a randomizer for each month. This will be revealed at the beginning of each month on whether to use Pedi-Cap or not. Other outcomes variables that will be assessed include initial heart rate (HR), time to HR > 100 bpm, duration of bradycardia, time to start of ventilation corrective maneuvers (if needed), maximum peak inspiratory pressure used, time to gold color change on Pedi-Cap, need for intubation, need for delayed PPV, need for chest compressions/epinephrine, need for neonatal intensive care unit admission if infant ≥35 gestational age, occurrence of pneumothorax, length of mechanical ventilation in days, and need for surfactant. Infant and maternal characteristics will be obtained from the electronic medical record. Association of outcomes with each study arm will be stratified by infant and maternal characteristics.

In addition, a survey will be administered to the resuscitation team members at the completion of the study to assess their experience with each study arm. ;

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disease
• Neonatal Resuscitation

• NCT number: NCT06258187
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Contact: Riti Chokshi, MD
• Phone: 214-456-5802
• Email: riti.chokshi@utsouthwestern.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Completion date: July 2025