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Premedication for Less Invasive Surfactant Administration

Study acronym: LISA-Med
StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated June 5, 2023 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Oct 31, 2022 to Oct 31, 2025
    • Study completion date: Oct 31, 2022 to Oct 31, 2026
    v4
  2. Notable Primary and study completion dates: Oct 31, 2020 to Oct 31, 2022v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2018 to Feb 11, 2019
    • Study sites: 0 to 1
    • Secondary endpoints: 4 to 5
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03735563
Lead Sponsor University of Oulu
Collaborators: Oulu University Hospital
Conditions
(from sponsor)
Surfactant Deficiency Syndrome Neonatal
Related terms Pulmonary Atelectasis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov