Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
|ClinicalTrials.gov Identifier: NCT01407848|
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Transient Tachypnoea of the Newborn||Drug: Furosemide Drug: Saline 0,9%||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.
Other Name: inhaled furosemide
Active Comparator: Saline 0,9%
Drug: Saline 0,9%
nebulised 0,9% saline 4x/d for max.3 days
Other Name: natrium chloride
- 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407848
|Children´s Hospital University of Cologne|
|Cologne, NRW, Germany, 50931|
|Principal Investigator:||Bernhard Roth, Prof. Dr.||University Cologne|