Actively Recruiting

Phase 4
All Genders
NCT03735563

Premedication for Less Invasive Surfactant Administration

Led by University of Oulu · Updated on 2023-06-05

40

Participants Needed

1

Research Sites

402 weeks

Total Duration

On this page

Sponsors

U

University of Oulu

Lead Sponsor

O

Oulu University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Premedication for Less Invasive Surfactant Administration

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age at birth 6 weeks
  • Respiratory insufficiency managed with non-invasive respiratory support (nasal continuous positive airway pressure or high-flow)
  • Need for oxygen to keep oxygen saturation within target range and requirement for surfactant treatment as assessed by clinician
  • Patients needing additional surfactant doses can be re-randomized
Not Eligible

You will not qualify if you...

  • Severe respiratory distress syndrome requiring ongoing ventilator support after surfactant therapy (intubation preferred if FiO2 >40% at gestational age <28 weeks or >60% at 6 weeks)
  • Maxillo-facial, tracheal, or known lung malformations
  • Any known chromosomal abnormality or severe malformation
  • Respiratory distress caused by other conditions such as congenital pneumonia or lung underdevelopment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Oulu University Hospital

Oulu, Finland

Actively Recruiting

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Research Team

E

Eveliina Ronkainen, MD, PhD

CONTACT

A

Antti Härmä, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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