E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Preterm infants still requiring mechanical ventilation at 7-10 days of life. |
Neonati pretermine che richiedono ancora una ventilazione meccanica a 7-10 giorni di vita. |
|
E.1.1.1 | Medical condition in easily understood language |
Preterm infants still requiring mechanical ventilation at 7-10 days of life. |
Neonati pretermine che richiedono ancora una ventilazione meccanica a 7-10 giorni di vita. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10076729 |
E.1.2 | Term | Very preterm infant |
E.1.2 | System Organ Class | 100000004868 |
|
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 test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the length of invasive mechanical ventilation. |
Verificare l'ipotesi che la somministrazione endotracheale di poractant-alfa preceduta da una manovra di reclutamento in modalità di ventilazione oscillatoria ad alta frequenza (HFOV) in neonati pretermine che richiedono ancora una ventilazione meccanica a 7-10 giorni di vita riduca la durata della ventilazione meccanica invasiva. |
|
E.2.2 | Secondary objectives of the trial |
Key secondary objective: To test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the rate of bronchopulmonary dysplasia. |
Obiettivo secondario principale: Verificare l'ipotesi che la somministrazione endotracheale di poractant-alfa preceduta da una manovra di reclutamento in modalità di ventilazione oscillatoria ad alta frequenza (HFOV) in neonati pretermine che richiedono ancora una ventilazione meccanica a 7-10 giorni di vita riduca l’incidenza di displasia broncopolmonare. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Extremely low gestational age newborn infants (GA < 28 weeks) – gestational age matching between maternal dates and/or early antenatal ultrasound 2. Singleton or multiple birth 3. Postnatal age between 7 and 10 days 4. Invasive mechanical ventilation still needed 5. Fraction of inspired oxygen (FiO2) of more than 0.30 and/or an oxygenation index of 8 or more for at least 6 hours 6. Stable cardiovascular condition 7. Informed consent form signed by parents or legal guardian |
1. Neonati di età gestazionale estremamente bassa - ELGANS (EG < 28 settimane) calcolata sulla base dell’ultima mestruazione e/o ecografia prenatale del primo trimestre 2. Nascite single o multiple 3. Età postnatale compresa tra il 7° ed il 10° giorno 4. Necessità di ventilazione meccanica invasiva 5. Frazione di ossigeno inspirato (FiO2) superiore a 0.30 e/o un oxygenation index pari a 8 o superiore per 6 ore consecutive 6. Conditioni cardiovascolari stabili 7. Consenso informato firmato dai genitori o rappresentanti legali del bambino |
|
E.4 | Principal exclusion criteria |
1. Major congenital malformation (i.e., infants with genetic, metabolic or endocrine disorder diagnosed before enrolment) 2. High index of suspicion of infection before enrolment 3. Neurological conditions that might contraindicate extubation 4. Inotropic agents needed 5. Pneumothorax 6. Hemodynamically significant ductus arteriosus 7. Surgical intervention within the past 72 hours 8. Partecipation in another interventional clinical study that may interfere with the results of this trial |
1. Malformazioni congenite maggiori (ad esempio, i bambini con disturbo genetico, metabolico o endocrino diagnosticato prima dell'arruolamento) 2. Forte sospetto di infezione 3. Condizioni neurologiche che potrebbero controindicare l'estubazione 4. Necessità di agenti inotropi 5. Pneumotorace 6. Dotto arterioso emodinamicamente pervio 7. Intervento chirurgico nelle precedent 72 ore 8. Partecipazione ad un altro studio clinic interventistico che possa interferire con I risultati di questo trial |
|
E.5 End points |
E.5.1 | Primary end point(s) |
First successful extubation (day of life) defined as extubation not followed by a reintubation for at least 7 days. |
Prima estubazione di successo (giorno di vita) definita come estubazione che non è stata seguita da reintubazione per i successivi 7 giorni |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Extubation will be considered successful when adequate spontaneous respiration will be maintained for at least 7 days. |
L'estubazione sarà considerata efficace quando verrà mantenuta un'adeguata respirazione spontanea nei successivi 7 giorni. |
|
E.5.2 | Secondary end point(s) |
Key secondary end-point: Rate of bronchopulmonary dysplasia expressed as the oxygen-dependance at 36 weeks of post-menstrual age. |
End-point secondario principale: Incidenza di broncodisplasia definite come ossigenodipendenza a 36 settimane di età post-mestruale. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From birth to discharge. |
Dalla nascita pretermine fino alla dimissione. |
|
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 | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
ventilazione meccanica secondo pratica clinica |
mechanical ventilation according to clinical practice |
|
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.8.4.1 | 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |