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CO2 Detector for Neonatal Resuscitation (CO2-Vent Trial)

N/A

Recruiting

Led By Riti Chokshi

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from birth to date of discharge or death, whichever comes first, assessed up to 50 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a colorimetric carbon dioxide detector called Pedi-Cap during face mask ventilation for newborn infants can reduce the time needed for ventilation. The study will involve a neon

Who is the study for?

This trial is for newborn infants born at or after 30 weeks' gestation who need non-invasive positive pressure ventilation (PPV) in the delivery room. The neonatal resuscitation team must be present before delivery to participate.

What is being tested?

The study tests if using a Pedi-Cap, which detects carbon dioxide, can reduce the time newborns need face mask PPV in the delivery room. Infants are randomly assigned monthly to either use or not use the Pedi-Cap during PPV.

What are the potential side effects?

There are no direct side effects from using a Pedi-Cap as it's a non-invasive monitoring device. However, its usage may influence decisions on how long to continue PPV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from birth to date of discharge or death, whichever comes first, assessed up to 50 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from birth to date of discharge or death, whichever comes first, assessed up to 50 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth to date of discharge or death, whichever comes first, assessed up to 50 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of positive pressure ventilation (PPV)

Secondary study objectives

Duration of bradycardia

Duration of mechanical ventilation

Maximum peak inspiratory pressure used

+9 more

Other study objectives

Initial heart rate at birth

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pedi-CapExperimental Treatment1 Intervention

A Pedi-Cap will be connected to the T-piece resuscitator in between the T-piece and face mask. With effective gas exchange, carbon dioxide (CO2) is detected by the Pedi-cap and will demonstrate gold color change with each exhalation. If there is no CO2 gas exchanged, the Pedi-Cap color will remain purple. The color change will be used as one of the tools for the resuscitation team to determine if the infant has effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation. Other ways, in addition to the Pedi-Cap, to determine effective PPV include a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation.

Group II: No Pedi-CapActive Control1 Intervention

There will be no Pedi-Cap attached to the t-piece resuscitator. Effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation will be assessed by a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation.

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