Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns (NCT04287907) | Clinical Trial Compass
CompletedNot Applicable
Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns
Singapore50 participantsStarted 2019-06-06
Plain-language summary
Effective ventilation is the single most vital intervention to improve outcome of resuscitation in the neonatal population. Assessments of effective ventilations are based on clinical parameters, but may be difficult due to inexperienced personnel as well as observer variability. End tidal CO2 detectors (ETCO2) have been shown to improve effective ventilation in manikin model as well as in video recordings of selective infants where obstructive breaths were recognized objectively by means of lack of colour change.
This is a trial evaluating the use of a qualitative end tidal CO2 monitor device during mask ventilation in the delivery room. The investigators hypothesize that using a colorimetric carbon dioxide detector during mask ventilation, it could facilitate recognition of obstructed breaths and reduce the duration of bradycardia and desaturations.
Who can participate
Age range
60 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.
Exclusion criteria
. Infants with impaired pulmonary circulation (eg. Cardiac arrest, pulmonary atresia, severe pulmonary stenosis
. Infants with congenital airway anomalies
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 trial used CO2 detectors to check whether breaths were actually reaching the baby's lungs during resuscitation — can you explain whether that kind of monitoring is already being used in your NICU, or if it's still considered experimental?
2The trial measured how long preterm babies spent with low heart rate (bradycardia) and low oxygen levels (desaturation) during resuscitation — what do those outcomes mean for my baby's short- and long-term health, and how does your team currently monitor for them?
3Since this trial is now completed, have any results been published yet, and if so, do they suggest CO2 detectors meaningfully improved resuscitation quality for preterm newborns?
4My baby may be born preterm — based on what this trial was studying, what does your resuscitation team currently do to confirm that each breath is effectively delivered, and is there anything I should know about how that process works?
5Are there other completed or ongoing studies on resuscitation techniques for preterm newborns that you think are more directly relevant to my situation, or would the findings from this CO2 detector trial change anything about my baby's care plan?
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
Bradycardia and Desaturation Duration
Timeframe: This outcome will be obtained immediately after birth when available on pulse oximetry