Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Cologne
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Transient Tachypnea of the Newborn
Tachypnea
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014