E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
TRATAMIENTO DE LAS APNEAS EN PACIENTES CON BRONQUIOLITIS AGUDA |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002972 |
E.1.2 | Term | Apnea |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000686 |
E.1.2 | Term | Acute bronchiolitis |
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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 |
El objetivo primario del estudio es demostrar que la administración de cafeína citrato por vía oral en pacientes con bronquiolitis aguda que presentan pausas respiratorias provoca una disminución del número de apneas. |
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E.2.2 | Secondary objectives of the trial |
1. Determinar la duración del ingreso. 2. Determinar la tasa y duración del ingreso en UCIP. 3. Determinar la tasa de ventilación no invasiva y la tasa de ventilación invasiva, y su duración. 4. Determinar la seguridad y tolerancia de cafeína citrato en estos pacientes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Edad de inclusión de 0 a 12 meses. 2. Pacientes que consulten por apneas (uno o más episodios), o las presenten durante su ingreso. 3. Pacientes que presenten clínica de bronquiolitis, la desarrollen en días posteriores o presenten un test para virus respiratorios positivo. 4. Consentimiento informado de los padres/representante legal. |
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E.4 | Principal exclusion criteria |
1. Cardiopatía. 2. Fibrosis quística. 3. Epilepsia. 4. Hipertiroidismo 5. Reflujo gastroesofágico. 6. Atresia de coanas. 7. Inmunodeficiencia. 8. Enfermedad neurológica. 9. Presentar datos clínicos o analíticos de sepsis. 10. Estar intubado en el momento de la inclusión. 11. Alergia o hipersensibilidad conocida al principio activo del fármaco en investigación o a cualquiera de sus excipientes. 12. Tratamiento en otro ensayo clínico. 13. Cualquier enfermedad concomitante grave que en la opinión del investigador pueda comprometer completar el estudio o afectar la tolerancia del paciente para este tratamiento. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Se determinarán el número de apneas por día. Se considerarán apneas las pauses respiratorias iguales o mayores a 20 segundos de duración, o bien de duración inferior pero asociadas a bradicardia inferior a 80 latidos por minuto, cianosis, palidez y/o hipotonía marcada. |
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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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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.8.3 |
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |