Premedication Options for Less Invasive Surfactant Treatment
Premedication for Less Invasive Surfactant Administration
Recruiting
Phase 4Interventional 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.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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 surfactant to a spontaneously breathing infant through a thin catheter. This technique minimizes the risk for neonatal lung injury caused by positive pressure ventilation. LISA is nowadays widely used in neonatal intensive care units (NICU). Although less invasive, newborns exposed to this procedure need premedication prior the procedure. There is no consensus, which drug would be the optimal premedication for LISA and the research on this topic is lacking. An ideal premedication would treat the procedural pain without suppressing the infant's own breathing. The sedation and analgesia should start fast but the effect should be short-acting with as few adverse effects as possible. 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.
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…
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 (according to clinician's assessment)
* If further doses of surfactant are needed, patient can be re-randomized
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 (intubation in preferable to LISA if FiO2 \>40% at GA \<28 weeks and \>60% at GA ≥28 weeks)
* 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)
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