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.

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

PCO2 Level Outside of Desired Range (40-60 mmHg)

Timeframe: Admission to NICU, approximately 1 hour of life

Trial details

NCT IDNCT01381068

SponsorNeil Finer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-05

Results submitted2019-08-22

View on ClinicalTrials.gov More Delivery Room Resuscitation trials