E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open ductus arteriosus of a premature infant |
Pienen keskosen valtimotiehyen viivästynyt sulketuminen |
|
E.1.1.1 | Medical condition in easily understood language |
Open ductus arteriosus |
Valtimotiehyen viivästynyt sulketuminen |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] |
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 |
To study the efficacy and safety of intravenous paracetamol in contracting ductus arteriosus of a very premature (<28 gestation weeks) or extremely low birth weight (<1000 g) infants |
Selvittää suonensisäisen parasetamolin turvallisuutta ja tehoa erittäin epäkypsien (<H28) tai pienipainoisten (<1000 g) keskosten duktuksen sulkeutumisessa. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All extremely premature (born before 28 gestation weeks) or low birth weight (< 1000 g) infants treated in neonatal intensive care unit of Oulu University Hospital and who have an open ductus |
Kaikki OYS:n Lasten teholla hoidetut, ennen 28+0 raskausviikkoa syntyneet tai syntymäpainoltaan alle 1000 g keskoset, joilla duktus on vielä avoinna, ja vanhemmilta saadaan tutkimuslupa. |
|
E.4 | Principal exclusion criteria |
- Denial by the parents
- Severe congenital or chromosomal anomaly or severe clinical situation, that complicates the standard ductal therapies e.g. asphyxia, or persistent pulmonary hypertension of a newborn |
Vanhempien kieltäytyminen, vaikea rakenne- tai kromosomipoikkeavuus tai muu vaikea kliininen tilanne, joka vaikeuttaa olennaisesti pienen keskosen tavanomaista alkuvaiheen hoitoa, esimerkiksi vaikea asfyksia tai koholla oleva keuhkoverenpaine (PPHN) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Shortening of the ductal closure time |
Duktuksen sulkeutumisajan lyheneminen |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
- after the study drug period
- at the discharge from the NICU |
- tutkimuslääkkeen jälkeen
- poistuminen teho-osastolta |
|
E.5.2 | Secondary end point(s) |
Cardiac ultrasound findings, ductal therapies, duration of the ventilation assist, paracetamol serum concentrations, possible paracetamol side effects, complications of prematurity, neonatal and long term morbidity and mortality |
Sydämen ultraäänilöydökset, duktushoidot, respiraattorihoidon kesto, parasetamolipitoisuudet, parasetamolin sivuvaikutukset, keskosuuden komplikaatiot, pitkäaikaissairastavuus ja kuolleisuus. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- discharge to home |
- kotiutuminen |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
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 | 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 | 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 | Yes |
E.8.2.3 | Other | No |
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 | Yes |
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
|
LVLS |
Viimeisen tutkimuspotilaan kotiutuminen |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |