Premedication for Less Invasive Surfactant Administration
Status:
Recruiting
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
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.