Premedication for less invasive surfactant administratio

Phase 1

Conditions: 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.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2018-002383-38-FI

Lead Sponsor: niversity of Oulu

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

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

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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