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

Phase 2

Completed

• Conditions: Transient Tachypnoea of the Newborn
• Interventions: Drug: Saline 0,9%; Drug: Furosemide

• Registration Number: NCT01407848
• Lead Sponsor: University of Cologne

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Study Start: 2012-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• 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 >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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline 0,9%	Saline 0,9%	1ml/kg/Ed
Furosemide	Furosemide	1 mg/kg/Ed

Primary Outcome Measures

Name	Time	Method
Reduction of the Silverman-Score	0-72 h or up to end of CPAP after start of the study	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.

Secondary Outcome Measures

Name	Time	Method
blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)	0-72 h after start of the study
body weight	1-3 day of life
Oxygen supplementation	0-72 h or up to end of CPAP after start of the study
A need for secondary intubation and mechanical ventilation	1-3 day of life
CPAP-time	0-72 h or up to end of CPAP after start of the study
blood gas (pH, pCO2,pO2)	0-72 h after start of the study

Trial Locations

Locations (1)

Children´s Hospital University of Cologne; 🇩🇪 Cologne, NRW, Germany