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

University of Cologne20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Transient Tachypnoea of the Newborn

Interventions

FurosemideDRUG

Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.

Saline 0,9%DRUG

nebulised 0,9% saline 4x/d for max.3 days

Eligibility

Sex: ALLMin age: 6 Hours

Medical Language ↔ Plain English

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

Locations (1)

Children´s Hospital University of Cologne

Cologne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Reduction of the Silverman-Score

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.

Time frame: 0-72 h or up to end of CPAP after start of the study

Secondary Outcomes

Oxygen supplementation

Time frame: 0-72 h or up to end of CPAP after start of the study

A need for secondary intubation and mechanical ventilation

Time frame: 1-3 day of life

body weight

Time frame: 1-3 day of life

CPAP-time

Time frame: 0-72 h or up to end of CPAP after start of the study

blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)

Time frame: 0-72 h after start of the study

blood gas (pH, pCO2,pO2)

Time frame: 0-72 h after start of the study

Data from ClinicalTrials.gov

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