Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
|Transient Tachypnoea of the Newborn||Drug: Furosemide Drug: Saline 0,9%||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea|
- 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 ]
|Study Start Date:||January 2012|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407848
|Children´s Hospital University of Cologne|
|Cologne, NRW, Germany, 50931|
|Principal Investigator:||Bernhard Roth, Prof. Dr.||University Cologne|