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

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

Not Recruiting
30 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study details
    Neonatal Resuscitation
    Neonatal Disease

NCT06258187

University of Texas Southwestern Medical Center

5 December 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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