Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
This study is not yet open for participant recruitment.
Verified October 2011 by University of Cologne
Sponsor:
University of Cologne
Information provided by (Responsible Party):
Patrizia Nitsch-Felsecker, University of Cologne
ClinicalTrials.gov Identifier:
NCT01407848
First received: July 28, 2011
Last updated: October 18, 2011
Last verified: October 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 28, 2011 | ||||||||
| Last Updated Date | October 18, 2011 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reduction of the Silverman-Score [ Time Frame: 0-72 h or up to end of CPAP after start of the study ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01407848 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea | ||||||||
| Official Title ICMJE | Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea | ||||||||
| Brief Summary | In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Transient Tachypnoea of the Newborn | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | August 2014 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01407848 | ||||||||
| Other Study ID Numbers ICMJE | Uni-Koeln-1488, 2011-003473-29 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Patrizia Nitsch-Felsecker, University of Cologne | ||||||||
| Study Sponsor ICMJE | University of Cologne | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of Cologne | ||||||||
| Verification Date | October 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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