The AeroFact Study

A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of AeroFact (SF-RI 1 surfactant for inhalation combined
with a dedicated delivery system) in Preterm Infants with Respiratory Distress Syndrome

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Respiratory issues
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All genders
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No minimum age

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Overview
Principal Investigator: Rachana Singh, MD, MS

The objective of this study is to determine whether AeroFact (SF-RI 1
surfactant for inhalation combined with a dedicated delivery system) can
decrease the incidence of failure of non-invasive support (nasal continuous
positive airway pressure [nCPAP] or non-invasive ventilation [NIV])
within the first 7 days of life, without increasing any of the significant
complications of prematurity, in infants with respiratory distress syndrome
(RDS).

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Juliet Ali-Caccamo, CRC

Study details
Inclusion Criteria
  • Age Requirement: 26 to 33 weeks GA at birth

    Inborn at Tufts Medical Center
  • Post-natal age 1 to 24 hours at randomization
  • On nCPAP or NIV for at least 30 minutes with respiratory severity
    score (RSS) = 1.4 – 2.0 to maintain SpO2 90-95%. RSS is calculated
    as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm
    H2O) × (FiO2).
Exclusion Criteria
  • On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC; > 2
    liters per minute [LPM]) at the time of randomization. These support
    systems are excluded because they cannot interface with the AeroFact
    system and/or do not provide accurate measurement of nCPAP level.
  • Prior instillation of surfactant
  • Premature rupture of membranes (PROM) occurring > 14 days before
    birth
Study Requirements

Treatment plus follow up to 24 months from randomization. Follow up includes respiratory questionnaires every 3 months with additional testing at 12 and 24 months.