Transient Tachypnoea of the Newborn
Conditions
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.
Interventions
DRUGFurosemide
Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.
DRUGSaline 0,9%
nebulised 0,9% saline 4x/d for max.3 days
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Hours to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the Silverman-Score | 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
| Measure | Time frame |
|---|---|
| A need for secondary intubation and mechanical ventilation | 1-3 day of life |
| body weight | 1-3 day of life |
| Oxygen supplementation | 0-72 h or up to end of CPAP after start of the study |
| blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-) | 0-72 h after start of the study |
| blood gas (pH, pCO2,pO2) | 0-72 h after start of the study |
| CPAP-time | 0-72 h or up to end of CPAP after start of the study |
Countries
Germany
Outcome results
None listed