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New treatment option for Surfactant Deficiency Syndrome Neonatal
Official title Premedication for Less Invasive Surfactant Administration
ClinicalTrials.gov ID: NCT03735563
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for surfactant deficiency syndrome neonatal.
Also referred to as Ketanest-S.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Early respiratory management of preterm infants immediately after birth should be as gentle as possible. With this so-called developmental approach, unnecessary invasive methods can be avoided or at least postponed.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Gestational age at birth ≥26 weeks
- Respiratory insufficiency managed with non-invasive respiratory support (nasal continuous positive airway pressure or high-flow)
- Requirement for oxygen to maintain oxygen saturation 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-assigned by chance
You likely can't join if
- Severe RDS with high oxygen requirements, severe respiratory acidosis and/or widespread atelectasis radiologically, such that ongoing ventilator...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Oulu, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oulu, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.