E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim of this randomized, controlled trial is to evaluate the feasibility, efficacy and safety of less invasive surfactant administration (LISA) protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol. |
Tutkimuksemme tavoitteena on selvittää, onnistuuko vähemmän kajoava surfaktantin annostelu (less invasive surfactant administration, LISA) paremmin joko ketamiini- tai fentanyyliesilääkitystä käyttäen. |
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E.1.1.1 | Medical condition in easily understood language |
Our aim is to study whether ketamine of fentanyl would be better premedication in less invasive surfactant administration. |
Tutkimuksemme tavoitteena on selvittää, onnistuuko vähemmän kajoava surfaktantin annostelu paremmin joko ketamiini- tai fentanyyliesilääkitystä käyttäen. |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of this randomized, controlled trial is to evaluate the feasibility, efficacy and safety of less invasive surfactant administration (LISA) protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol. |
Tutkimuksemme tavoitteena on selvittää, onnistuuko LISA-toimenpide paremmin joko ketamiini- tai fentanyyliesilääkitystä käyttäen. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Gestational age at birth ≥26 weeks; respiratory insufficiency managed with non-invasive respiratory support (nasal CPAP or high-flow); requirement for oxygen to maintain oxygen saturation (SpO2) in the target range and need for surfactant treatment (according to clinician’s assessment); if further doses of surfactant are needed, patient can be re-randomized
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Syntymägestaatioikä ≥ 26 viikkoa; hengitysvaikeus, jonka hoitona nCPAP tai korkeavirtausviikset; lisähapentarve ja surfaktantin tarve (kliinikon arvion mukaan); uusinta-annoksen tarve 6-12 h kuluessa (randomoidaan uudestaan)
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E.4 | Principal exclusion criteria |
Severe RDS with high oxygen requirements, severe respiratory acidosis and/or widespread atelectasis radiologically, such that ongoing ventilator support will be necessary after surfactant therapy; maxillo-facial, tracheal or known pulmonary malformations; any known chromosomal abnormality or severe malformation; an alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia) |
Vaikea RDS ja suuri lisähapentarve, vaikea respiratorinen asidoosi ja/tai laajat atelektaasit keuhkokuvassa siten, että hengityskonehoito on tarpeen surfaktantin annon jälkeen; yläleuan, kasvojen, trakean tai keuhkojen malformaatio; tiedetty kromosomaalinen poikkeavuus tai vakava malformaatio; muu syy hengitysvaikeudelle (esim. kongenitaalinen pneumonia tai keuhkohypoplasia) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Adverse events: the need of positive pressure ventilation (PPV), intubation, heart rate below 80 per minute, mean arterial pressure (MAP) change more than 20%, pH change more than 0.4, and CO2 change more than 20%, and saturation <85 for more than 1 minute. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 minutes after the procedure |
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E.5.2 | Secondary end point(s) |
Age at procedure, FiO2, pH and partial pressure of carbon dioxide (PaCO2), SpO2, blood pressure, heart rate, and near-infrared spectroscopy (NIRS), pharmacokinetic, pharmacodynamic, dose response |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before, during and after LISA |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |