Premedication Options for Less Invasive Surfactant Treatment

Premedication for Less Invasive Surfactant Administration

Recruiting Phase 4 Interventional Study
Surfactant Deficiency Syndrome Neonatal
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Oulu · Other
Who this trial is looking for

This trial is looking for preterm infants with breathing issues who need surfactant treatment. Participants will receive one of two medications, either ketamine or fentanyl, to see which one works better for their care.

Are You a Good Fit for This Trial?

You may be able to join if

  • I was born at 26 weeks gestation or later.
  • I need help breathing with non-invasive support.
  • I require oxygen to keep my oxygen levels in the right range.
  • I need surfactant treatment as assessed by my doctor.
  • If I need more surfactant, I can join again.

You may not be able to join if

  • I have severe respiratory distress that needs a ventilator.
  • I have known issues with my face, throat, or lungs.
  • I have a chromosomal abnormality or severe malformation.
  • I have respiratory distress due to another known cause.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial
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. This kind of "soft landing" allows cardiorespiratory transition with fewer adverse outcomes. Less invasive surfactant administration (LISA) is a technique that involves delivery of sur…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 (a…
Contacts

Eveliina Ronkainen, MD, PhD

+358 8 3152011

eveliina.ronkainen@oulu.fi

CONTACT

Antti Härmä, MD

+358 8 3152011

aharma@paju.oulu.fi

CONTACT