RecruitingPhase 4NCT03735563

Premedication for Less Invasive Surfactant Administration


Sponsor

University of Oulu

Enrollment

40 participants

Start Date

Feb 11, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fentanyl and a drug called Ketamine for people with surfactant deficiency syndrome neonatal. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

Individuals will receive randomly either ketamine or fentanyl as a premedication

DRUGFentanyl

Individuals will receive randomly either ketamine or fentanyl as a premedication


Locations(1)

Oulu University Hospital

Oulu, Finland

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NCT03735563


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