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

Primary Purpose

Transient Tachypnoea of the Newborn

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Furosemide

Saline 0,9%

About this trial

This is an interventional treatment trial for Transient Tachypnoea of the Newborn

Eligibility Criteria

6 Hours - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children´s Hospital University of Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Furosemide

Saline 0,9%

Arm Description

1 mg/kg/Ed

1ml/kg/Ed

Outcomes

Primary Outcome Measures

Reduction of the Silverman-Score

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

A need for secondary intubation and mechanical ventilation

body weight

CPAP-time

blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)

blood gas (pH, pCO2,pO2)

Full Information

NCT ID

NCT01407848

First Posted

July 28, 2011

Last Updated

September 22, 2015

Sponsor

University of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT01407848

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cologne

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transient Tachypnoea of the Newborn

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Furosemide

Arm Type

Experimental

Arm Description

1 mg/kg/Ed

Arm Title

Saline 0,9%

Arm Type

Active Comparator

Arm Description

1ml/kg/Ed

Intervention Type

Drug

Intervention Name(s)

Furosemide

Other Intervention Name(s)

inhaled furosemide

Intervention Description

Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.

Intervention Type

Drug

Intervention Name(s)

Saline 0,9%

Other Intervention Name(s)

natrium chloride

Intervention Description

nebulised 0,9% saline 4x/d for max.3 days

Primary Outcome Measure Information:

Title

Reduction of the Silverman-Score

Description

Time Frame

0-72 h or up to end of CPAP after start of the study

Secondary Outcome Measure Information:

Title

Oxygen supplementation

Time Frame

0-72 h or up to end of CPAP after start of the study

Title

A need for secondary intubation and mechanical ventilation

Time Frame

1-3 day of life

Title

body weight

Time Frame

1-3 day of life

Title

CPAP-time

Time Frame

0-72 h or up to end of CPAP after start of the study

Title

blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)

Time Frame

0-72 h after start of the study

Title

blood gas (pH, pCO2,pO2)

Time Frame

0-72 h after start of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Hours

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernhard Roth, Prof. Dr.

Organizational Affiliation

University Cologne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children´s Hospital University of Cologne

City

Cologne

State/Province

NRW

ZIP/Postal Code

50931

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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