E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Preterm newborns of less than/or equal to 36 weeks of gestational age who have an umbilical venous or arterial catheter which, for nutritional and/or therapeutic needs, must be replaced by a percutaneous central venous catheter (PICC). |
Neonati pretermine di età gestazionale inferiore/uguale a 36 settimane portatori di catetere venoso ombelicale che, per esigenze nutrizionali e/o terapeutiche, si sottoporranno a posizionamento di catetere venoso centrale percutaneo (PICC). |
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E.1.1.1 | Medical condition in easily understood language |
Preterm infants who need percutaneous central venous catheter insertion |
Neonati pretermine a cui deve essere inserito un catetere venoso centrale percutaneo |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
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 | 100000004865 |
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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 |
To define the pharmacokinetics of intranasal dexmedetomidine (after a dose of 3 µg/kg), in preterm babies of less than/or equal to 36 weeks of gestational age, who have an umbilical venous or arterial catheter which, for nutritional and/or therapeutic needs, must be replaced by a percutaneous central venous catheter (PICC). The umbilical catheters will be used for serial blood micro-sampling, thus avoiding additional pain. |
L’obiettivo principale di questo studio è di definire la farmacocinetica della dexmedetomidina somministrata per via intranasale, alla dose di 3 µg/kg, in una popolazione di pretermine di età gestazionale inferiore/uguale a 36 settimane, portatori di catetere venoso ombelicale che, per esigenze nutrizionali e/o terapeutiche, devono essere sottoposti a posizionamento di catetere venoso centrale percutaneo (PICC) sfruttando il catetere ombelicale per microprelievi di sangue seriati senza causare dolore. |
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E.2.2 | Secondary objectives of the trial |
To define the clinical efficacy (sedation / pain reduction) of dexmedetomidine using the PIPP-R scale (Premature Infant Pain Profile- Revised) during the insertion of a percutaneous venous catheter. |
L’obiettivo secondario di questo studio consiste nel definire l’efficacia clinica (sedazione/riduzione del dolore) del farmaco mediante scala PIPP (premature infant pain profile) durante la procedura di posizionamento del catetere venoso percutaneo in concomitanza alla raccolta ematica per l’analisi farmacocinetica. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Gestational age from 28 to 36 weeks with a minimum weight of 1 kg (50° percentile at 28 weeks of GA) 2. Patent umbilical catheter already in place (venous or arterial) 3. Need for a percutaneous venous catheter for nutritional and/or therapeutic purposes in elective conditions 4. Consent to the study participation and to the off-label use of dexmedetomidine 5. Drug therapies not included in the exclusion criteria |
1. Età gestazionale da 28 a 36 settimane con un peso minimo di 1 kg (50° percentile a 28 settimane di GA) 2. Presenza di catetere ombelicale refluente (venoso o arterioso) 3. Necessità di un catetere venoso percutaneo per scopi nutrizionali e/o terapeutici in condizioni elettive 4. Consenso alla partecipazione allo studio e all'uso off-label della dexmedetomidina 5. Terapie farmacologiche non incluse nei criteri di esclusione |
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E.4 | Principal exclusion criteria |
1. Need for a percutaneous venous catheter in emergency conditions 2. Cardiac instability (such as arrhythmias or significant cardiac dysfunctions), hemodynamically significant congenital heart disease 3. Bradycardia at the time of enrolment with HR < 100 4. Hypotension at the time of enrolment with mean BP less than GA 5. Beta blocker or digoxin therapy or drugs acting on the atrio-ventricular node 6. IVH 3-4 7. Administration of sedative or anaesthetic drugs in the 8 hours prior to enrolment 8. Any nasal obstruction that might impair the intranasal drug administration/absorption 9. Craniofacial anomalies associated with difficulty in ventilation through a mask or intubation 10. Liver disease characterised by AST > 100 U/L; ALT > 80 U/L; BD > 2 mg/dL or >20% of total bilirubin |
1. Necessità di un catetere venoso percutaneo in condizioni di emergenza 2. Instabilità cardiaca nota (aritmie o disfunzioni cardiache significative, cardiopatia congenita emodinamicamente significativa); 3. Bradicardia al momento dell'arruolamento con HR < 100; 4. Ipotensione al momento dell'arruolamento con pressione sanguigna media minore rispetto al valore dell’età gestazionale 5. Terapia con betabloccanti o digossina o farmaci che agiscono sul nodo atrio-ventricolare; 6. IVH 3-4°; 7. Somministrazione di farmaci sedativi o anestetici nelle 8 ore precedenti l’arruolamento; 8. Qualsiasi ostruzione nasale che potrebbe compromettere la somministrazione/assorbimento intranasale del farmaco; 9. Anomalie cranio-facciali associate a difficoltà di ventilazione tramite maschera o intubazione; 10. Malattia epatica caratterizzata da AST > 100 U/L; ALT > 80 U/L; BD > 2 mg/dL o >20% della bilirubina totale |
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E.5 End points |
E.5.1 | Primary end point(s) |
The aim of the study is to define the pharmacokinetics of dexmedetomidine, administered intranasally, in preterm infants. |
L'obiettivo dello studio è quello di definire la farmacocinetica della dexemedetodimina somministrata per via intranasale nei neonati pretermine. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- The clinical efficacy of the drug (pharmacodynamics) expressed by the score of the PIPP scale, assessed during the procedure according to the blood concentration of the drug; The variation of vital parameters (heart rate, oxygen saturation, blood pressure) associated with the concentration of the drug |
- L'efficacia clinica del farmaco (farmacodinamica) espressa dal punteggio della scala PIPP, valutata durante la procedura in base alla concentrazione ematica del farmaco; La variazione dei parametri vitali (frequenza cardiaca, saturazione di ossigeno, pressione sanguigna) associati alla concentrazione del farmaco |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 minutes; 12 hours |
30 minuti; 12 ore |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |