Non Inferiority Trial Investigating Surfactants Administered Via MIST

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Endeavor Health
Study ID
NCT06074380
Phase
PHASE4
Status
Recruiting
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Conditions

  • Respiratory Distress Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - 48 Hours
Healthy Volunteers
Not accepted

Interventions

  • MIST surfactant — DRUG
    Surfactant will be given via MIST while neonate is on CPAP

Study Details

RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST. Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. Babies who require emergent intubation will not be enrolled in the interventions. Parental Consent will be obtained prior to randomization.

Key Dates

Start date
Jan 1, 2024
Status verified
Aug 2025
Primary completion
Dec 30, 2025
Completion
Dec 1, 2027

Study Design

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

Arms

  • Experimental: Calfactant (Infasurf)
    Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP \> 30% oxygen will be given 3ml/kg of Calfacant
  • Experimental: Poractant alfa (Curosurf)
    Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP \> 30% oxygen will be given 2.5ml/kg of Poractant alfa.

Primary Outcome Measure

Number of infants requiring Endotracheal Intubation [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northshore University HealthsystemEvanstonIllinois60201
Matthew Derrick, mbbs
[email protected]
8475702920

Find similar trials in Evanston, IL

By research site
Northshore University Healthsystem· Evanston, IL

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