NCT01407848.
Trial name or title | Trial on treatment with inhaled furosemide of preterm and term neonates with transient tachypnoea |
Methods | Estimated enrolment: 20 Randomised, double‐blind trial Parallel assignment 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 trial; malformation and any other of several diseases with respiratory disturbance; participants involved in other clinical trials |
Participants | Preterm and term neonates with transient tachypnoea |
Interventions | Patients received nebulised Furosemide IV solution 1 mg/kg (4x/d) for max. 3 consecutive days versus nebulised 0.9% saline 4x/d for max. 3 days |
Outcomes | Primary outcome: Reduction of the Silverman score Secondary outcome: Oxygen supplementation, a need for secondary intubation and mechanical ventilation, body weight, CPAP‐time, blood electrolytes, and blood gas |
Starting date | January 2012 |
Contact information | Prof. Bernhard Roth Children's Hospital University of Cologne Cologne, NRW, Germany, 50931 +49221478 ext 5064 bernd.roth@uk‐koeln.de |
Notes | NCT01407848 |
CPAP: continuous positive airway pressure GA: gestational age h: hour(s)