Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR) (NCT01381068) | Clinical Trial Compass
CompletedNot Applicable
Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
United States50 participantsStarted 2009-10
Plain-language summary
This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU.
Who can participate
Age range
15 Minutes
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:
* Need for ventilation in the delivery room
Exclusion Criteria:
* Tracheal suctioning for meconium
* Congenital Diaphragmatic Hernia
* Suspected hypoplasia of the lungs
* Oligohydramnios \<28 weeks gestation or AFI\<5
* Known or suspected airway anomaly
* Mother not speaking English or Spanish
* Refusal of consent
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.
1This study monitored CO2 levels during delivery room resuscitation — can you explain what it means for a baby's CO2 to be outside the 40–60 mmHg range, and why that range matters for newborn outcomes?
2Since this trial is completed, has the research been published, and if so, what did it find about whether real-time end-tidal CO2 monitoring actually helped keep newborns within a safer CO2 range during resuscitation?
3This study focused on the delivery room specifically — does our hospital or birth center currently use end-tidal CO2 monitoring during newborn resuscitation, and if not, is there evidence supporting its use that our care team considers?
4Because this was a monitoring study rather than a drug or procedure trial, what does the evidence say about whether having this kind of CO2 feedback changes what medical staff do during resuscitation, and whether that translates to better outcomes for the baby?
5Given that this trial has no listed phase, which suggests it may have been more observational or feasibility-focused, how much weight should we give its findings compared to larger randomized trials when thinking about resuscitation care for our newborn?
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
PCO2 Level Outside of Desired Range (40-60 mmHg)
Timeframe: Admission to NICU, approximately 1 hour of life