Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea

University of Cologne

Status and phase: Completed; Phase 2

Conditions: Transient Tachypnoea of the Newborn

Treatments: Drug: Saline 0,9%; Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT01407848

2011-003473-29 (EudraCT Number)

Uni-Koeln-1488

Details and patient eligibility

About

In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea.

Full description

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 so long as need a CPAP-treatment but max. 3 days. 20 Patient will be treating.

The benefit will be measured as reduction of dyspnea, respiratory rate, oxygen demand and time on CPAP.

Enrollment: 20 patients

Sex: All

Ages: 6+ hours old

Volunteers: No Healthy Volunteers

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 >92%
• Written informed consent of parent/guardian

Exclusion criteria

• Systemic infection
• Intubation and mechanical ventilation before Inclusion in the trail
• Malformation and any other several disease with disturb of respiratory
• Subjects participating in other clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Furosemide

Experimental group

Description:

1 mg/kg/Ed

Treatment:

Drug: Furosemide

Saline 0,9%

Active Comparator group

Description:

1ml/kg/Ed

Treatment:

Drug: Saline 0,9%