Exploratory Propofol Dose Finding Study In Neonates
NEOPROP
Prospective Exploratory Dose-finding Study in Neonates Receiving a Single Intravenous Propofol Bolus for Endotracheal Intubation During (Semi-)Elective INSURE Procedure or Non-INSURE Procedures in Neonates
2 other identifiers
interventional
50
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
June 18, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
July 30, 2024
CompletedJuly 30, 2024
August 1, 2012
1.9 years
June 8, 2012
April 14, 2023
July 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effective Dose for 50% of Patients for Succesful Intubation and Subsequent Extubation in Case of Planned Extubation After INSURE Procedure
An up-and-down dose-response design was used to calculate ED50 (mg/kg) in strata with effective sampling size of at least 6, by use of the Dixon-Massey method for small samples.
1 hour after propofol administration
Other Outcomes (1)
Intubation Condition Score
After final intubation.
Study Arms (1)
propofol
OTHERAll patients receive propofol. Dose will be defined based on response of previous patient in the same stratum.
Interventions
Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.
Eligibility Criteria
You may qualify if:
- Patients can be included if they are hemodynamically stable and did not receive sedative or analgesic agents during the previous 24 hours.
You may not qualify if:
- Known propofol intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neonatal Intensive Care Unit UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
Related Publications (1)
Smits A, Thewissen L, Caicedo A, Naulaers G, Allegaert K. Propofol Dose-Finding to Reach Optimal Effect for (Semi-)Elective Intubation in Neonates. J Pediatr. 2016 Dec;179:54-60.e9. doi: 10.1016/j.jpeds.2016.07.049. Epub 2016 Sep 2.
PMID: 27597733DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Liesbeth Thewissen, MD, PhD
- Organization
- UZ Leuven, NICU
Study Officials
- PRINCIPAL INVESTIGATOR
Liesbeth Thewissen, MD
UZ Leuven, Belgium
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2012
First Posted
June 18, 2012
Study Start
August 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
July 30, 2024
Results First Posted
July 30, 2024
Record last verified: 2012-08