Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Oulu University Hospital
Oulu, Finland
Actively Recruiting
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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