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Study identifier: NCT03735563 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Premedication for Less Invasive Surfactant Administration

Condition: Surfactant Deficiency Syndrome Neonatal  ·  Sponsor: University of Oulu

PhasePhase 4
Planned participants40
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Eveliina Ronkainen, MD, PhD  ·  +358 8 3152011  ·  eveliina.ronkainen@oulu.fi

Antti Härmä, MD  ·  +358 8 3152011  ·  aharma@paju.oulu.fi

Always discuss trial participation with your own doctor first.

Locations (1)

Oulu University HospitalOulu, FinlandRecruiting

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Source record: clinicaltrials.gov/study/NCT03735563