BridgeMD
Remifentanil for endotracheal intubation in neonates: a dose-finding trial.
EU CTIS ID: 2022-501858-11-00
What this study is testing
Because data on optimal remifentanil dosing and its pharmacodynamic effects (PD) in preterm and term neonates are limited we will perform a prospective dose-finding study with PD assessment in neonates receiving remifentanil as premedication for semi-elective endotracheal intubation. The primary outcome measure is to determine the age-specific bolus dose of remifentanil (ED90) that provides adequate intubating conditions (effective sedation) in 90% of subjects with minimal side effects.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Hemodynamic stable term or preterm neonate (normal mean blood pressure, without use of inotropic agents or vasopressors.
- Requiring semi-elective endotracheal intubation.
- Minimum of 26 weeks gestational age.
- Written informed consent obtained from the legal representatives.
You likely can't join if
- 5th min Apgar score less than 5.
- Maxillofacial anomalies.
- Anticipated difficult airwaiy (e.g. airway anomaly or obstruction).
- Concurrent or recent intravenous opioids infusions within 24 hours of the procedure.
- Neonates from non-Dutch speaking parents
- Infants born via cesarian section under general anesthesia 12 hours prior to enrollment.
See the full eligibility criteria
- Hemodynamic stable term or preterm neonate (normal mean blood pressure, without use of inotropic agents or vasopressors.
- Requiring semi-elective endotracheal intubation.
- Minimum of 26 weeks gestational age.
- Written informed consent obtained from the legal representatives.
- 5th min Apgar score less than 5.
- Maxillofacial anomalies.
- Anticipated difficult airwaiy (e.g. airway anomaly or obstruction).
- Concurrent or recent intravenous opioids infusions within 24 hours of the procedure.
- Neonates from non-Dutch speaking parents
- Infants born via cesarian section under general anesthesia 12 hours prior to enrollment.
- Neonates from mothers with recent drug abuse
- Prior enrollment in the trial.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.