Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room (NCT06258187) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room
United States632 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range
30 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of positive pressure ventilation (PPV)
Timeframe: From birth to end of delivery room resuscitation or admission to the Neonatal Intensive Care Unit (NICU) (approximately 1 hour of life)
Trial details
NCT IDNCT06258187
SponsorUniversity of Texas Southwestern Medical Center