CompletedPhase 2

Exploratory Propofol Dose Finding Study In Neonates

Belgium50 participantsStarted 2012-08

Plain-language 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).

Who can participate

Age range1 Day – 28 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure

Timeframe: 1 hour after propofol administration

Trial details

NCT IDNCT01621373

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07

Results submitted2023-04-14

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