Exploratory Propofol Dose Finding Study In Neonates (NEOPROP)

Universitaire Ziekenhuizen KU Leuven

Status and phase

Completed

Phase 2

Conditions

Neonatal Disorder

Adverse Reaction to Drug

Treatments

Drug: propofol administration

Study type

Interventional

Funder types

Other

Identifiers

NCT01621373

s54472

2012-002648-26 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

The aim of the study is to evaluate the pharmacokinetics and pharmacodynamics of propofol (short acting anesthetic) in 50 neonates to whom the drug is administered as a intravenous bolus. This is part of routine clinical care in patients receiving (semi-) elective intubation. It's the aim to explore the most effective IV propofol dose for a successful INSURE (intubation, surfactant, extubation) procedure and for successful (semi-) elective intubation in non-INSURE procedures. We hereby aim to define the most optimal dose regimen for propofol in neonates.

Intubation condition score was assessed retrospectively by the intubating physician.

Enrollment

50 patients

Sex

All

Ages

1 to 28 days old

Volunteers

No Healthy Volunteers

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