Trial on treatment with inhaled furosemide of preterm and term neonates with transient tachypnoea

• Conditions: 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.; MedDRA version: 14.1Level: PTClassification code 10044403Term: Transient tachypnoea of the newbornSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2011-003473-29-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-11
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified