Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room (NCT03770104) | Clinical Trial Compass
UnknownNot Applicable
Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room
Spain280 participantsStarted 2019-01-01
Plain-language summary
The investigators wished to determine whether estimating endotracheal tube (ETT) insertion depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather than the depth using the formula given by international guidelines recommendations (6 plus weight) resulted in more correctly positioned endotracheal tube tips in newborns intubated in the delivery room.
Who can participate
Age range
1 Day
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:
* All newborns requiring endotracheal oral intubation in the delivery room after birth.
* Parents accept deferred informed consent to participate in the study.
Exclusion Criteria:
* Prior to randomization
* Uncontrolled gestation where both estimated fetal weight and gestational age are unknown.
* Upper airway anomaly or a lung anomaly that would distort the upper airway anatomy.
* Infants who require nasotracheal intubation
* Infants who are intubated in the Neonatal Intensive Care Unit
* Post-randomization
* Newborns who are randomized but finally do not require intubation
* Intubated newborns who are electively extubated in the delivery room
* Parents / legal guardian refuse to give consent to participate in the study
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
Frequency of correct endotracheal tube (ETT) position