Trial on Treatment With Inhaled Furosemide of Preterm and... | NCT01407848

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

NCT01407848

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Transient Tachypnoea of the Newborn

Interventions

Furosemide
Saline 0,9%

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-003473-29	EudraCT Number

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jul 28, 2011

First Submission Date that Met QC Criteria

Aug 1, 2011

First Posted Date

Aug 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Furosemide	Experimental	1 mg/kg/Ed	Drug: Furosemide
Saline 0,9%	Active Comparator	1ml/kg/Ed	Drug: Saline 0,9%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Furosemide	Drug	Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.	Furosemide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	0-72 h or up to end of CPAP after start of the study

Secondary Outcomes

Measure	Description	Time Frame
Oxygen supplementation		0-72 h or up to end of CPAP after start of the study
A need for secondary intubation and mechanical ventilation		1-3 day of life
body weight

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Hours

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernhard Roth, Prof. Dr.	University Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children´s Hospital University of Cologne		Cologne	North Rhine-Westphalia	50931	Germany

Condition Browse Module

MeSH Terms

ID	Term
D059245	Transient Tachypnea of the Newborn

Ancestor Terms

ID	Term
D012127	Respiratory Distress Syndrome, Newborn
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005665	Furosemide

Ancestor Terms

ID	Term
D013424	Sulfanilamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided