- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407848
Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
NRW
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Cologne, NRW, Germany, 50931
- Children´s Hospital University of Cologne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Furosemide
1 mg/kg/Ed
|
Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.
Other Names:
|
Active Comparator: Saline 0,9%
1ml/kg/Ed
|
nebulised 0,9% saline 4x/d for max.3 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of the Silverman-Score
Time Frame: 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. |
0-72 h or up to end of CPAP after start of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oxygen supplementation
Time Frame: 0-72 h or up to end of CPAP after start of the study
|
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
|
1-3 day of life
|
body weight
Time Frame: 1-3 day of life
|
1-3 day of life
|
CPAP-time
Time Frame: 0-72 h or up to end of CPAP after start of the study
|
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
|
0-72 h after start of the study
|
blood gas (pH, pCO2,pO2)
Time Frame: 0-72 h after start of the study
|
0-72 h after start of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bernhard Roth, Prof. Dr., University Cologne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Signs and Symptoms, Respiratory
- Infant, Premature, Diseases
- Respiratory Distress Syndrome, Newborn
- Respiratory Distress Syndrome
- Tachypnea
- Transient Tachypnea of the Newborn
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
Other Study ID Numbers
- Uni-Koeln-1488
- 2011-003473-29 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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