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

Study Overview
=================
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.

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

Conditions
-----------------
Transient Tachypnoea of the Newborn

Intervention / Treatment
-----------------
* Drug: Furosemide
* Drug: Saline 0,9%


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide<br>1 mg/kg/Ed | Drug: Furosemide<br>* Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.<br>* Other names: inhaled furosemide;|
| Active Comparator: Saline 0,9%<br>1ml/kg/Ed | Drug: Saline 0,9%<br>* nebulised 0,9% saline 4x/d for max.3 days<br>* Other names: natrium chloride;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-72 h or up to end of CPAP after start of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| body weight |  | 1-3 day of life | 
| CPAP-time |  | 0-72 h or up to end of CPAP after start of the study | 
| blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-) |  | 0-72 h after start of the study | 
| blood gas (pH, pCO2,pO2) |  | 0-72 h after start of the study |