Prophylactic Minimally Invasive Surfactant Evaluation

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Endeavor Health
Study ID
NCT06007547
Phase
PHASE4
Status
Recruiting
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Conditions

  • Premature Birth
  • Respiratory Distress Syndrome, Newborn

Eligibility Criteria

Sex
ALL
Age
N/A - 15 Minutes
Healthy Volunteers
Accepted

Interventions

  • Poractant Alfa — DRUG
    Poractant alfa (Curosurf) 200mg/kg administered under direct laryngoscopy using a surfactant instillation catheter

Study Details

The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?

Key Dates

Start date
Jan 1, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prophylactic Surfactant via Minimally Invasive Technique
    Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes).
  • Active Comparator: Rescue Surfactant via Minimally Invasive Technique
    The control group will be given surfactant will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg if their fiO2 reaches a threshold of ≥30% within the first 48 hours of life.

Primary Outcome Measure

Endotracheal Intubation [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northshore University HealthsystemEvanstonIllinois60201
Matthew Derrick, mbbs
[email protected]
847-570-2920

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By research site
Northshore University Healthsystem· Evanston, IL

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