CO2 Detector for Neonatal Resuscitation

(CO2-Vent Trial)

Overseen By Riti Chokshi, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Gestation <30 weeks, Immediate intubation, Comfort care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Approximately 1 hour of life

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a device called Pedi-Cap can assist newborns needing breathing support immediately after birth. The Pedi-Cap, a color-changing tool, helps doctors and nurses check if a baby is exhaling carbon dioxide properly, potentially reducing the time the baby requires breathing assistance. Some newborns will receive care with the Pedi-Cap, while others will not, to compare outcomes. Babies born at or after 30 weeks who need breathing support are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance newborn care.

Do I need to stop my current medications for this trial?

The trial does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Pedi-Cap CO2 Detector is safe for neonatal resuscitation?

Research has shown that CO2 detectors, such as the Pedi-Cap, are safely used in newborns during resuscitation. These devices help ensure correct placement of breathing tubes by changing color with each breath, allowing the medical team to monitor the baby's breathing. Studies have found that using these detectors can reduce complications in infants, particularly those at risk of changes in blood flow to the brain. This indicates that the Pedi-Cap is generally well-tolerated in newborns, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pedi-Cap because it introduces an innovative way to assess effective neonatal resuscitation by using color change to indicate carbon dioxide (CO2) exchange. Unlike standard methods that rely solely on monitoring heart rate, infant color, chest rise, and oxygen saturation, the Pedi-Cap provides immediate visual confirmation of effective ventilation through a simple color shift from purple to gold with each exhalation. This real-time feedback can help the resuscitation team quickly determine if a newborn is receiving adequate non-invasive positive pressure ventilation (PPV), potentially improving response times and outcomes in critical delivery room situations.

What evidence suggests that the Pedi-Cap CO2 Detector is effective for neonatal resuscitation?

In this trial, some participants will use the Pedi-Cap, a device that changes color, during newborn resuscitation. Studies have shown that the Pedi-Cap turns gold before a baby's heart rate significantly increases, confirming that the baby receives enough air. This helps the resuscitation team determine if they provide sufficient air to the baby. Additionally, it has proven effective in confirming the correct placement of breathing tubes in newborns. The Pedi-Cap offers immediate feedback, leading to faster and more accurate resuscitation efforts. ^{1 3 4 6 7}

Who Is on the Research Team?

Riti Chokshi

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

A resuscitation team must be present before delivery.

My baby was born at or after 30 weeks of pregnancy.

I require a machine to help me breathe.

Exclusion Criteria

My infant needs immediate breathing support due to a birth defect.

No non-invasive PPV needed in the delivery room

Infants who have a prenatal plan of comfort care only

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Neonatal resuscitation team uses or does not use the Pedi-Cap during face mask PPV for infants born at ≥30 weeks' gestation in the delivery room

Approximately 1 hour of life

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of mechanical ventilation duration and need for NICU admission

Up to 50 weeks

Survey

Resuscitation team members complete a survey to assess their experience with each study arm

What Are the Treatments Tested in This Trial?

Interventions

• Pedi-Cap

Trial Overview

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.

How Is the Trial Designed?

Group I: Pedi-Cap Experimental Treatment 1 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-Cap Active Control 1 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Using a CO2 detector during manual ventilation significantly improves the effectiveness of positive pressure ventilation in neonatal resuscitation, especially within the first minute, with effective ventilation rates of 90% for T-piece alone, 94% for Pedi-Cap, and 96% for Neo-Stat.

Among 19 pediatric trainees who performed a total of 7,790 ventilations, the Neo-Stat CO2 detector was preferred by two-thirds of the participants, indicating a strong preference for this device in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and user preference of two CO2 detectors in an infant mannequin randomized crossover trial. Hawkes, GA., O'Connell, BJ., Livingstone, V., et al.[2021]

Colorimetric carbon dioxide detectors are effective tools for confirming proper endotracheal tube placement and ensuring a clear airway during bag and mask ventilation.

In a prospective, randomized trial, these detectors were observed to aid in preintubation airway stabilization, highlighting their utility in emergency medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disposable colorimetric carbon dioxide detector use as an indicator of a patent airway during noninvasive mask ventilation. Leone, TA., Lange, A., Rich, W., et al.[2013]

The Pedi-CAP disposable ETCO2 detector demonstrated high accuracy in verifying endotracheal tube placement in newborns, with a sensitivity of 91% and specificity of 100%, making it a reliable tool for neonatal resuscitation.

Using the Pedi-CAP significantly reduced the time needed to confirm proper tube placement to an average of 8.1 seconds, compared to 39.7 seconds with clinical evaluation, which is crucial for quickly identifying and correcting misplacements, especially in vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pediatric disposable end-tidal carbon dioxide detector role in endotracheal intubation in newborns. Aziz, HF., Martin, JB., Moore, JJ.[2019]

The study found that the Mini StatCO2 detector can detect a breath-to-breath color change at a tidal volume as low as 0.83 mL, while the Pedi-Cap detector requires a minimum tidal volume of 1.08 mL, indicating their sensitivity for use in neonates.

These findings suggest that both colorimetric carbon dioxide detectors are suitable for confirming endotracheal intubation in neonates, even those weighing as little as 400 grams, enhancing safety in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tidal volume threshold for colorimetric carbon dioxide detectors available for use in neonates. Garey, DM., Ward, R., Rich, W., et al.[2013]

The disposable colorimetric CO2 detector demonstrated 100% sensitivity for confirming endotracheal intubation in patients with a palpable pulse, indicating it is highly effective in these cases.

In patients experiencing cardiac arrest, the detector's sensitivity dropped to 72%, suggesting that while it is generally reliable, its effectiveness in critical situations may require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Verification of endotracheal tube placement with colorimetric end-tidal CO2 detection. MacLeod, BA., Heller, MB., Gerard, J., et al.[2022]

Maintaining normal CO2 levels in newborns is crucial for preventing chronic lung disease and brain damage, but traditional arterial sampling can be risky and requires frequent blood draws.

Alternative CO2 measurement methods, like end-tidal CO2 and colorimetric detectors, can be useful, especially during emergencies, but arterial blood gas measurements (Pa(CO2)) remain the most reliable for assessing CO2 levels in neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are carbon dioxide detectors useful in neonates? Molloy, EJ., Deakins, K.[2018]

In a study of 41 newborns with bradycardia receiving mask ventilation, the Pedi-Cap's color change indicating CO₂ levels preceded a significant increase in heart rate, demonstrating its potential as an early indicator of improved respiratory function during neonatal resuscitation.

The use of the Pedi-Cap not only provided immediate feedback on CO₂ levels but also correlated with increased oxygen saturation, making it a valuable, electricity-free tool for neonatal resuscitation, particularly in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pedi-cap color change precedes a significant increase in heart rate during neonatal resuscitation. Blank, D., Rich, W., Leone, T., et al.[2022]

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The aim of this study was to determine if Pedi-Cap gold color change during neonatal resuscitation precedes an increase in heart rate in babies with ...

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CO2 Detector for Neonatal Resuscitation (CO2-Vent Trial)

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