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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002648-26 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol | Other | All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol administration | Drug | Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Intubation Condition Score | Intubation condition score at final intubation was assessed retrospectively by the intubating physician. The score as described by Viby-Mogensen was used, with the evaluation of laryngoscopy, vocal cords, coughing, jaw relaxation and limb movements. The minimum score of the intubation condition score is 5, the maximum score of the intubation condition score is 20. A score less or equal to 10 defines a good intubation condition. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liesbeth Thewissen, MD | UZ Leuven, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit UZ Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27597733 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum. propofol administration: Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | All patients receive propofol. Dose will be defined based on response of previous patient in the same stratum. propofol administration: Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 8 strata defined by postmenstrual age and postnatal age, primary outcome of propofol ED 50 in mg/dl could be calculated in stratum 1,3 and 5. | Posted | Mean | 95% Confidence Interval | mg/kg | 1 hour after propofol administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Particpants | Permissive hypotension was noted with a duration of blood pressure decrease at least 120-200 minutes after propofol administration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liesbeth Thewissen, MD, PhD | UZ Leuven, NICU | 003216343211 | liesbeth.thewissen@uzleuven.be |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| After final intubation. |
| Participants |
|
| Age, Continuous | Median | Full Range | day |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Postmenstrual age 28 to< 32 w Postnatal age < 10 days
| OG002 | Stratum 5 | Postmenstrual age 32 to < 37 w Postnatal age < 10 days |
|
|
| Other Pre-specified | Intubation Condition Score | Intubation condition score at final intubation was assessed retrospectively by the intubating physician. The score as described by Viby-Mogensen was used, with the evaluation of laryngoscopy, vocal cords, coughing, jaw relaxation and limb movements. The minimum score of the intubation condition score is 5, the maximum score of the intubation condition score is 20. A score less or equal to 10 defines a good intubation condition. | Posted | Median | Full Range | score on a scale | After final intubation. |
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|
| 0 |
| 50 |
| 0 |
| 50 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |