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

Running, not enrolling · Not applicable

Conditions studied: Neonatal Resuscitation, Neonatal Disease

In brief

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.

Key facts

Study ID

NCT06258187

Run by

University of Texas Southwestern Medical Center

People needed

632

Starts

2024-03-01

Expected to finish

2026-03-30

Last updated by the study team

2026-03-02

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born at ≥30 weeks' gestation
• Presence of the resuscitation team prior to delivery
• Need for non-invasive positive pressure ventilation (PPV).

You may not qualify if…

• Infants born at <30 weeks' gestation
• No non-invasive PPV needed in the delivery room
• Infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia
• Resuscitation team not present prior to delivery/need for PPV
• Infants who have a prenatal plan of comfort care only

Where it is running

• Parkland Health — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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