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Completed

NCT Number: NCT01407848

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

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

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Key information

Conditions

Transient Tachypnoea of the Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachypnea Transient Tachypnea of the Newborn

Age range

6 hour and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children´s Hospital University of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

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

Other names: inhaled furosemide

Saline 0,9%

Drug

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

Other names: natrium chloride

Primary outcomes

  1. Reduction of the Silverman-Score

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

    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 outcomes

  1. Oxygen supplementation

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

  2. A need for secondary intubation and mechanical ventilation

    Time frame: 1-3 day of life

  3. body weight

    Time frame: 1-3 day of life

  4. CPAP-time

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

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

    Time frame: 0-72 h after start of the study

  6. blood gas (pH, pCO2,pO2)

    Time frame: 0-72 h after start of the study

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 2, 2011
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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