E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Very preterm birth |
Grande prématurité |
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E.1.1.1 | Medical condition in easily understood language |
Very preterm birth |
Grande prématurité |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053593 |
E.1.2 | Term | Premature baby 26 to 32 weeks |
E.1.2 | System Organ Class | 100000004868 |
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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 demonstrate the effectiveness of a 50% reduced betamethasone dose regimen to prevent severe respiratory distress syndrome (RDS) associated with very preterm birth. |
Démontrer l'efficacité d'une demi-dose de bétaméthasone pour prévenir la maladie des membranes hyalines (MMH) sévère associée à la grande prématurité |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate the effectiveness of a 50% reduced betamethasone dose regimen to prevent the other neonatal complications associated with very preterm birth. |
Démontrer l'efficacité d'une demi-dose de bétaméthasone pour prévenir les autres complications néonatales associées à la grande prématurité |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Singleton pregnancy - Patient who has already received the first injection of betamethasone and term pregnancy <32 weeks of gestation - Age > or = 18 years - Patient with health insurance coverage
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- Grossesse monofoetale - Patiente ayant déjà reçu la 1ere injection de bétaméthasone et terme de grossesse <32SA - Age > ou = 18 ans - Patiente affiliée à un regime de sécurité sociale ou CMU |
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E.4 | Principal exclusion criteria |
- Chromosomal aberrations and major fetal malformations - Cervical dilatation > ou = 4 cm - Patient who has already received a first betamethasone course |
- Anomalies chromosomiques et syndrome malformatif majeur - Dilatation cervicale > ou = à 4 cm - Patiente ayant déjà reçu une première cure de betaméthasone.
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E.5 End points |
E.5.1 | Primary end point(s) |
Severe respiratory distress syndrome (RDS) defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life. |
Maladie des membranes hyalines (MMH) sévère définie comme un recours au surfactant exogène dans les 48 premières heures de vie. |
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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) |
Related to the severity of RDS - highest appropriate fractional inspired oxygen (FiO2) in the first 48 hours of life - maximum appropriate Mean Airway Pressure (MAP) - use and duration of mechanical ventilation - use and duration of oxygen therapy - need for oxygen therapy after 36 weeks post conception
Related to betamethasone impact on other prematurity-induced complications - neonatal death - admission to neonatal intensive care unit - use of inotropic support - air leak syndrome - patent ducutus arteriosus - necrotising enterocolitis grade > II - intraventricular hemorrhage and its grade - periventricular leukomalacia - use of postnatal steroids - retinopathy of prematurity - length of hospital stay
Related to potential adverse events - birth weight - head circonference at birth - body length at birth - early onset sepsis |
Liés à la sévérité de la MMH - FiO2 maximale durant les premières 48h de vie - Pression moyenne maximale de ventilation pendant les premières 48h de vie - Durée de la ventilation mécanique et de ventilation non invasive - Utilisation et durée de l'oxygénothérapie - Besoin d'une ventilation et/ou d'une oxygénothérapie après 36 semaines d'âge gestationnel corrigé
Liés à l'impact de la bétaméthasone sur les autres complications de la prématurité - décès neonatal - admission en unité de réanimation néonatale - utilisation d'un support hémodynamique par inotropes - pneumothorax - persistance du canal artériel traité médicalement ou chirurgicalement - entérocolite ulcéronécrosante de grade > II - hémorragie intra-ventriculaire et son grade - leucomalacie périventriculaire - utilisation de corticoïdes en postnatal - rétinopathie du prématuré traitée - durée totale d'hospitalisation avant sortie à domicile
Liés à de potentiels effets indésirables - poids de naissance - périmètre céphalique à la naissance - taille à la naissance - infection néonatale précoce |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
48 hours and 37 weeks of corrected gestational age. |
48 heures et 37 SA d'âge gestationnel corrigé |
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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 | No |
E.6.5 | Efficacy | No |
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) | No |
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 | 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.8.2.3.1 | 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
| 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 | 41 |
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
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |