E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with transient tachypnoea. Patients received nebulised Furosemide iv solution 1 mg/kg or nebulised 0,9% saline (4x/d) under blind conditions in random order on 3 consecutive days. 20 Patient will be treating. |
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E.1.1.1 | Medical condition in easily understood language |
transient tachypnoea or wet lung disease |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10044403 |
E.1.2 | Term | Transient tachypnoea of the newborn |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 |
The primary endpoint of the study is the reduction of the Silverman score as an indicator of respiratory distress of the infant.
Silverman Score is the standard score to describe the degree of respiratory distress of neonate.
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E.2.2 | Secondary objectives of the trial |
• Decrease of the CPAP-time
• Oxygen supplementation
• A need for secondary intubation and mechanical ventilation
• The safety of the inhaled application of an i.v. Furosemide solution will be determined.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Neonates with 35+0-39+0 GA on the first day of life with the clinical diagnosis of Transient Tachypnoea
•The need for CPAP >6 h to obtain the oxygen saturation>90%
•Written informed consent of parent/guardian
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E.4 | Principal exclusion criteria |
•Systemic infection
•Intubation and mechanical ventilation before inclusion in the trial
•Malformation and any other several disease with disturb of respiratory
•Subjects participating in other clinical trials
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is the development of the Silverman score after inhalation of trial drug |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
until 26 h after treatment start |
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E.5.2 | Secondary end point(s) |
• Decrease of the CPAP-time
• Oxygen supplementation
• need for secondary intubation and mechanical ventilation
• safety |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
until 72 h until treatment start |
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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 | 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 | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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
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The end of treatment is third day of life or end of the CPAP-treatment from last patient. End of trial is end of the follow up from the last patient or time of discharge ( max. 14 day after birth)(LVLS) |
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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 | |
E.8.9.1 | In the Member State concerned days | 14 |