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

Transient Tachypnoea of the Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407848
• Other study ID #: Uni-Koeln-1488
• Secondary ID: 2011-003473-29
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2011
• Last updated: September 22, 2015
• Start date: January 2012
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachypnea
• Transient Tachypnea of the Newborn
• Transient Tachypnoea of the Newborn

Intervention

Drug:
• Furosemide
Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.
• Saline 0,9%
nebulised 0,9% saline 4x/d for max.3 days

Locations

Country	Name	City	State
Germany	Children´s Hospital University of Cologne	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Oxygen supplementation		0-72 h or up to end of CPAP after start of the study	No
Secondary	A need for secondary intubation and mechanical ventilation		1-3 day of life	No
Secondary	body weight		1-3 day of life	Yes
Secondary	CPAP-time		0-72 h or up to end of CPAP after start of the study	No
Secondary	blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)		0-72 h after start of the study	Yes
Secondary	blood gas (pH, pCO2,pO2)		0-72 h after start of the study	Yes