E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tutkittavat ovat raskausviikoilla 23-27 syntyviä keskosia, joilla on keskosuutensa vuoksi riski sairastua BPD:hen (bronkopulmonaarinen dysplasia, keskosen krooninen keuhkosairaus). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006475 |
E.1.2 | Term | Bronchopulmonary dysplasia |
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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 |
Tutkia <12h:n iässä aloitetun budesonidi-lääkityksen vaikutus BPD:hen sairastumiseen (määriteltynä gestaatioviikolla H36). |
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E.2.2 | Secondary objectives of the trial |
Kokonaiskuolleisuus H37 mennessä, BPD:n esiintyvyys H36, hengitystuen (joko cpap tai lisähappi) tarpeen kesto, neurologinen kehitys määriteltynä korjatussa 18-22kk:n iässä, budenosidi-hoidon sivuvaikutukset, budenosidin farmakokineettinen ja farmakodynaaminen analyysi, IVH:n (intraventricular hemorhage, keskosen aivoverenvuoto) esiintyvyys, PLV:n (periventrikulaarinen leukomalasia) esiintyvyys, PDA:n (patent ductus arteriosus, sulkeutumaton valtimotiehyt) esiintyvyys, ROP:n (keskosen retinopatian) esiintyvyys, NEC (nekrotisoivan enterokoliitin) esiintyys, infektioden esiintyvyys, potilaiden kasvu, sairaalahoidon kesto. Osatutkimuksessa lisäksi BPD:n geneettisten riskitekijöiden ja farmakogenetiikan analyysi. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
NEUROSIS-GEN: Efficacy and safety of inhaled Budesonide (Steroid) in very preterm infants at risk for Bronchopulmonary Dysplasia (BPD). Study on genetic risk factors of BPD and on pharmacogenetics of Steroid. |
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E.3 | Principal inclusion criteria |
Gestaatioikä H23-H27+6, postnataalinen ikä <12h, hengitystuentarve (joko cpap tai respiraattori), vanhempien suostumus osallistumiseen. |
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E.4 | Principal exclusion criteria |
Aktiivisen hoidon piiriin kuulumattomuus, dysmorfiset piirteet tai synnynnäiset epämuodostumat jota vaikuttavat heikentävästi eloonjäämisennusteeseen tai neurologiseen kehitykseen, synnynnäinen sydänvika tai epäily sellaisesta lukuunottamatta PDA (persistent ductus arteriosus) ja ASD (atrium septum defect). |
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E.5 End points |
E.5.1 | Primary end point(s) |
BPD:n kehittyminen tai kuolema ad H37 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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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 | 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 |