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RECRUITING
NCT03735563
PHASE4

Premedication for Less Invasive Surfactant Administration

Sponsor: University of Oulu

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2019-02-11

Completion Date

2026-10-31

Last Updated

2023-06-05

Healthy Volunteers

No

Interventions

DRUG

Ketamine

Individuals will receive randomly either ketamine or fentanyl as a premedication

DRUG

Fentanyl

Individuals will receive randomly either ketamine or fentanyl as a premedication

Locations (1)

Oulu University Hospital

Oulu, Finland