Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
This study is currently recruiting participants.
Verified April 2013 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: April 25, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea.
| Condition | Intervention | Phase |
|---|---|---|
|
Transient Tachypnoea of the Newborn |
Drug: Furosemide Drug: Saline 0,9% |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea |
Resource links provided by NLM:
Further study details as provided by University of Cologne:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Oxygen supplementation [ Time Frame: 0-72 h or up to end of CPAP after start of the study ] [ Designated as safety issue: No ]
- A need for secondary intubation and mechanical ventilation [ Time Frame: 1-3 day of life ] [ Designated as safety issue: No ]
- body weight [ Time Frame: 1-3 day of life ] [ Designated as safety issue: Yes ]
- CPAP-time [ Time Frame: 0-72 h or up to end of CPAP after start of the study ] [ Designated as safety issue: No ]
- blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-) [ Time Frame: 0-72 h after start of the study ] [ Designated as safety issue: Yes ]
- blood gas (pH, pCO2,pO2) [ Time Frame: 0-72 h after start of the study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Furosemide |
Drug: Furosemide
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
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407848
Contacts
| Contact: Bernhard Roth, Prof.Dr. | +49221478 ext 5064 | bernd.roth@uk-koeln.de |
| Contact: Patrizia Nitsch-Felsecker, Dr. med. | +49221478 ext 6853 | patrizia.nitsch-felsecker@uk-koeln.de |
Locations
| Germany | |
| Children´s Hospital University of Cologne | Recruiting |
| Cologne, NRW, Germany, 50931 | |
| Principal Investigator: Bernhard Roth, Prof.Dr.med. | |
| Sub-Investigator: Patrizia Nitsch-Felsecker, Dr.med. | |
Sponsors and Collaborators
University of Cologne
Investigators
| Principal Investigator: | Bernhard Roth, Prof. Dr. | University Cologne |
More Information
No publications provided
| Responsible Party: | Patrizia Nitsch-Felsecker, Dr. med., University of Cologne |
| ClinicalTrials.gov Identifier: | NCT01407848 History of Changes |
| Other Study ID Numbers: | Uni-Koeln-1488, 2011-003473-29 |
| Study First Received: | July 28, 2011 |
| Last Updated: | April 25, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Furosemide Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Diuretics Natriuretic Agents Physiological Effects of Drugs Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013