E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Investigation of the most effective intravenously administered single propofol dose for successful INSURE prodecure and for (semi-)elective intubation of neonates in non-INSURE conditions (e.g. surgery) in neonates. INSURE-procedure is defined as (semi-)elective intubation, intratracheal administration of surfactant and extubation within 60 minutes after propofol administration. |
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E.1.1.1 | Medical condition in easily understood language |
Investigation of the optimal dose of propofol to give when we want to put a tube in the airway of a baby to let him sleep. In certain babies we would like to remove the tube soon after the procedure. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028977 |
E.1.2 | Term | Neonate |
E.1.2 | System Organ Class | 100000004869 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067450 |
E.1.2 | Term | Endotracheal intubation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049124 |
E.1.2 | Term | Sedation during medical procedure |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061134 |
E.1.2 | Term | Drug level therapeutic |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-What is the most effective intravenously (iv) administered single propofol dose for successful INSURE prodecure in neonates? INSURE-procedure is defined as (semi-)elective intubation, intratracheal administration of surfactant and extubation within 60 minutes after propofol administration.
-What is the most effective intravenously (iv) administered single propofol dose for successful (semi-)elective intubation of neonates during non-INSURE conditions (e.g. surgery)? |
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E.2.2 | Secondary objectives of the trial |
- To document level of sedation and relaxation at fixed time points during the dose-finding study.
- To document PK/PD relation of propofol in neonates.
- To document new covariates of propofol pharmacokinetics in neonates.
- To document hemodynamic PD (side)effects of propofol during the dose-finding study in neonates and compare them with previous reports.
- To document other side effects of propofol during the dose-finding study in neonates and compare them with previous reports.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 hemodynamicaly stable and did not receive sedative or analgesic agents during the previous 24 hours. |
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E.4 | Principal exclusion criteria |
Known propofol intolerance
Exclusion based on opinion of attending physician |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of neonates where successful INSURE prodecure is achieved? INSURE-procedure is defined as (semi-)elective intubation, intratracheal administration of surfactant and extubation within 60 minutes after propofol administration. Number of neonates where successful (semi-)elective intubation during non-INSURE conditions (e.g. surgery) is achieved. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of succesfull intubation and in case of insure-procedures succesfull extubation based on predefined scores. (see flowchart) within 60 minutes after propofol administration. |
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E.5.2 | Secondary end point(s) |
Relaxation and sedationscore
intubation condition score
hemodynamic and neurological effects of propofol (vital parameters, cerebral oxygenation, aEEG)
propofol pharmacokinetics |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
relaxation and sedation score up to 5 minutes after propofol administration
intubation condition score directly after intubation
vital parameters, PK samples, cerebral oxygenation and aEEG during 12 hours after propofol administration. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |