Using a CO2 detector to improve face-mask ventilation for newborns
Randomized Control Trial of Colorimetric CO2 Detectors for Ventilation Assessment in the Delivery Room
This study is testing if using a special CO2 detector can help doctors ventilate newborns more effectively during delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 632 (estimated) |
| Ages | 30 Weeks and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06258187 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a colorimetric carbon dioxide detector, known as the Pedi-Cap, during face-mask ventilation for newborn infants in the delivery room. The neonatal resuscitation team will either use or not use the Pedi-Cap based on a monthly randomization scheme. Researchers will collect data from medical charts and surveys from the resuscitation team to assess various outcomes, including the duration of positive pressure ventilation and other critical health indicators. The goal is to determine if the Pedi-Cap can reduce the time needed for ventilation in infants born at or beyond 30 weeks' gestation.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at 30 weeks' gestation or later who require non-invasive positive pressure ventilation in the delivery room.
Not a fit: Patients who may not benefit from this study include those born before 30 weeks' gestation or those who require immediate intubation.
Why it matters
Potential benefit: If successful, this approach could lead to quicker and more effective resuscitation of newborns, potentially improving survival rates and reducing complications.
How similar studies have performed: While the use of CO2 detectors in neonatal resuscitation is a relatively novel approach, similar studies have shown promising results in improving ventilation outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas
- Parkland Health — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Riti Chokshi — University of Texas
- Study coordinator: Riti Chokshi, MD
- Email: riti.chokshi@utsouthwestern.edu
- Phone: 214-456-5802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.