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

NCT ID: NCT01407848

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Transient Tachypnoea of the Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Furosemide

1 mg/kg/Ed

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

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

Saline 0,9%

1ml/kg/Ed

Group Type ACTIVE_COMPARATOR

Saline 0,9%

Intervention Type DRUG

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

Interventions

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Furosemide

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

Intervention Type DRUG

Saline 0,9%

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

Intervention Type DRUG

Other Intervention Names

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inhaled furosemide natrium chloride

Eligibility Criteria

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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
Minimum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Patrizia Nitsch-Felsecker

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernhard Roth, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Cologne

Locations

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Children´s Hospital University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-003473-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Uni-Koeln-1488

Identifier Type: -

Identifier Source: org_study_id

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