Overview
Sponsor-declared trial summary
respiratory distress syndrome, surfactant treatment, premedication
The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of 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 proto…
Key facts
- Sponsor
- Pohjois-Pohjanmaan hyvinvointialue, University Of Oulu
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2025-01-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-520492-10-00
- EudraCT number
- 2018-002383-38
- ClinicalTrials.gov
- NCT03735563
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of 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 and MedDRA coding
respiratory distress syndrome, surfactant treatment, premedication
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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 in the target range and need for surfactant treatment (according to clinician’s assessment)
Exclusion criteria 4
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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)
Secondary endpoints 5
- Duration of the procedure
- Number of attempts to get the catether intratracheally
- Pain score NIAPAS
- The need for additional dosing of study drug or midazolam (number of addtional dosages)
- Edi-signals
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Ketanest-S 5 mg/ml injektio-/infuusioneste, liuos
PRD11825314 · Product
- Active substance
- Esketamine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 2 mg/kg milligram(s)/kilogram
- Max total dose
- 6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX14 — ESKETAMINE
- Marketing authorisation
- 13383
- MA holder
- PFIZER OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fentanyl-hameln 50 Mikrogramm/ml Injektionslösung
PRD3238594 · Product
- Active substance
- Fentanyl Citrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 2 µg/Kg microgram(s)/kilogram
- Max total dose
- 6 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 5 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AH01 — FENTANYL
- Marketing authorisation
- 49593.00.00
- MA holder
- HAMELN PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pohjois-Pohjanmaan hyvinvointialue
- Sponsor organisation
- Pohjois-Pohjanmaan hyvinvointialue
- Address
- Kajaanintie 50
- City
- Oulu
- Postcode
- 90220
- Country
- Finland
Scientific contact point
- Organisation
- Pohjois-Pohjanmaan hyvinvointialue
- Contact name
- Eveliina Ronkainen
Public contact point
- Organisation
- Pohjois-Pohjanmaan hyvinvointialue
- Contact name
- Eveliina Ronkainen
University Of Oulu
- Sponsor organisation
- University Of Oulu
- Address
- P. O. Box 23
- City
- Oulu
- Postcode
- 90029
- Country
- Finland
Scientific contact point
- Organisation
- University Of Oulu
- Contact name
- Eveliina Ronkainen
Public contact point
- Organisation
- University Of Oulu
- Contact name
- Eveliina Ronkainen
Sponsor responsibilities
- Article 77 compliance
- Pohjois-Pohjanmaan hyvinvointialue
- Contact point sponsor
- Pohjois-Pohjanmaan hyvinvointialue
- Article 77 implementation
- Pohjois-Pohjanmaan hyvinvointialue
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Research plan LISAMed 030918 | 1 |
| Recruitment arrangements (for publication) | Selvitys tutkittavien valinnasta ja suostumuksen saamiseksi noudatettavasta menettelysta | 1 |
| Subject information and informed consent form (for publication) | Subject information and informed consent 030918 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-07 | Finland | Acceptable 2025-01-28
|
2025-01-28 |