Clinical trial • Phase IV • Respiratory|Other

Esketamine hydrochloride for Respiratory distress syndrome

Phase IV trial of Esketamine hydrochloride for Respiratory distress syndrome.

Overview

Trial Therapeutic Area
Respiratory|Other
Trial Disease
Respiratory distress syndrome
Trial Stage
Phase IV
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
07-01-2025
First CTIS Authorization Date
28-01-2025

Trial design

Randomised, ketamine (ketanest-s 5 mg/ml injektio-/infuusioneste, liuos) versus fentanyl (fentanyl-hameln 50 mikrogramm/ml injektionslösung) as premedication; both administered by intravenous bolus. specific dosing regimen and schedule are not specified in the ctis record.-controlled Phase IV trial across 1 site in Finland.

Randomised
Yes
Comparator
Ketamine (Ketanest-S 5 mg/ml injektio-/infuusioneste, liuos) versus Fentanyl (Fentanyl-hameln 50 Mikrogramm/ml Injektionslösung) as premedication; both administered by intravenous bolus. Specific dosing regimen and schedule are not specified in the CTIS record.
Target Sample Size
40

Eligibility

Recruits 40 paediatric patients.

Vulnerable Population
Newborn infants (neonates); isVulnerablePopulationSelected = true. A subject information and informed consent form is listed in the trial documents ('Subject information and informed consent 030918').

Inclusion criteria

  • {"criterion_text":"- Gestational age at birth ≥26 weeks\n- Respiratory insufficiency managed with non-invasive respiratory support (nasal CPAP or high-flow)\n- Requirement for oxygen to maintain oxygen saturation in the target range and need for surfactant treatment (according to clinician’s assessment)"}

Exclusion criteria

  • {"criterion_text":"- 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\n- Maxillo-facial, tracheal or known pulmonary malformations\n- Any known chromosomal abnormality or severe malformation\n- An alternative cause for respiratory distress"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Any adverse event (the need of positive pressure ventilation, intubation, heart rate below 80/min, mean arterial pressure change more than 20%, pH change more than 0.4, CO2 change more than 20%, and saturation <85 for more than 1 minute)","definition_or_measurement_approach":"Defined as occurrence of any of the following: need of positive pressure ventilation, intubation, heart rate below 80/min, mean arterial pressure change >20%, pH change >0.4, CO2 change >20%, or oxygen saturation <85% for more than 1 minute."}

Secondary endpoints

  • {"endpoint_text":"- Duration of the procedure","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of attempts to get the catether intratracheally","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Pain score NIAPAS","definition_or_measurement_approach":"Measured using the NIAPAS pain score."}
  • {"endpoint_text":"- The need for additional dosing of study drug or midazolam (number of addtional dosages)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Edi-signals","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
40
Recruitment Window Months
104
Consent Approach
A subject information and informed consent form is listed in the trial documents ('Subject information and informed consent 030918'). No further details on who provides consent/assent, age-specific documents or languages available are provided in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Finland

Earliest CTIS Part Ii Submission Date
22-01-2025
Latest Decision Or Authorization Date
28-01-2025
Processing Time Days
6
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Pohjois-Pohjanmaan hyvinvointialue
Department Name
Vastasyntyneiden teho ja valvonta
Principal Investigator Name
Eveliina Ronkainen
Principal Investigator Email
eveliina.ronkainen@oulu.fi
Contact Person Name
Eveliina Ronkainen
Contact Person Email
eveliina.ronkainen@oulu.fi
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
Pohjois-Pohjanmaan hyvinvointialue
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Co-sponsors

  • University Of Oulu

Investigational products

Investigational Product Name
Ketanest-S 5 mg/ml injektio-/infuusioneste, liuos
Active Substance
Esketamine hydrochloride
Modality
Small molecule
Routes Of Administration
Intravenous bolus
Route
Intravenous bolus
Authorisation Status
Authorised product
Maximum Dose
Max daily dose: 2 mg/kg; Max total dose: 6 mg/kg
Investigational Product Name
Fentanyl-hameln 50 Mikrogramm/ml Injektionslösung
Active Substance
Fentanyl citrate
Modality
Small molecule
Routes Of Administration
Intravenous bolus
Route
Intravenous bolus
Authorisation Status
Authorised product
Maximum Dose
Max daily dose: 2 µg/kg; Max total dose: 6 µg/kg

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