The aim of this randomized, controlled trial is to evaluate the feasibility, efficacy and safety of less invasive surfactant administration (LISA) protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.
Conditions
Interventions
Trade Name: Ketanest-S
Pharmaceutical Form: Concentrate for solution for injection
Trade Name: Fentanyl-Hameln
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
University of Oulu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Gestational age at birth =26 weeks; respiratory insufficiency managed with non-invasive respiratory support (nasal CPAP or high-flow); requirement for oxygen to maintain oxygen saturation (SpO2) in the target range and need for surfactant treatment (according to clinician’s assessment); if further doses of surfactant are needed, patient can be re-randomized Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Severe RDS with high oxygen requirements, severe respiratory acidosis and/or widespread atelectasis radiologically, such that ongoing ventilator support will be necessary after surfactant therapy; maxillo-facial, tracheal or known pulmonary malformations; any known chromosomal abnormality or severe malformation; an alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this randomized, controlled trial is to evaluate the feasibility, efficacy and safety of less invasive surfactant administration (LISA) protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.;Secondary Objective: Not applicable;Primary end point(s): Adverse events: the need of positive pressure ventilation (PPV), intubation, heart rate below 80 per minute, mean arterial pressure (MAP) change more than 20%, pH change more than 0.4, and CO2 change more than 20%, and saturation <85 for more than 1 minute.;Timepoint(s) of evaluation of this end point: 30 minutes after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Age at procedure, FiO2, pH and partial pressure of carbon dioxide (PaCO2), SpO2, blood pressure, heart rate, and near-infrared spectroscopy (NIRS), pharmacokinetic, pharmacodynamic, dose response;Timepoint(s) of evaluation of this end point: Before, during and after LISA | — |
Countries
Finland
Contacts
Public Contactclinicaltrials.gov
University of Oulu
Outcome results
None listed