Phase 2
Completed N=50
Exploratory Propofol Dose Finding Study In Neonates
Adverse Reaction to Drug · Neonatal Disorder
Source: ClinicalTrials.gov NCT01621373 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure — 0.792; 0.713; 1.350 mg/kg
Summary
The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective non-INSURE procedures (term-preterm neonates).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure |
0.792; 0.713; 1.350 | — |
Eligibility Criteria
Inclusion Criteria
- Neonates admitted to the Neonatal Intensive Care Unit who need short procedural sedation for (semi-) elective intubation will be considered for inclusion, after informed written consent of the parents.
- Patients can be included if they are hemodynamically stable and did not receive sedative or analgesic agents during the previous 24 hours.
Exclusion Criteria
- Known propofol intolerance
Data sourced from ClinicalTrials.gov (NCT01621373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.