NCT06258187

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 632 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 30 Weeks
• Healthy volunteers: Not accepted

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 to either use the Pedi-Cap or not use the Pedi-Cap. The researchers will collect information from the medical chart to find the infant and mother's information, 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 facemask PPV.

Detailed 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 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 opening an opaque envelope each month. This will be revealed at the beginning of each month on whether to use the 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, maximum peek inspiratory pressure used, maximum fractionated inspired oxygen, 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, doses of surfactant given, and survival to discharge. 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.

Conditions

• Neonatal Resuscitation
• Neonatal Disease

Interventions

Type	Name	Description
DEVICE	Pedi-Cap	The neonatal resuscitation team will include or omit the use of Pedi-Cap during non-invasive positive pressure ventilation (PPV) for infants ≥30 weeks in the delivery room based on the randomized study arm each month.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2026-03-30
• First posted: 2024-02-14
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study