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ACTIVE NOT RECRUITING
NCT06258187
NA

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

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

30 Weeks - Any

Study Type

INTERVENTIONAL

Enrollment

632

Start Date

2024-03-01

Completion Date

2026-03-30

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

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.

Locations (1)

Parkland Health

Dallas, Texas, United States