Actively Recruiting
InfasurfAero 22 Versus Sham Treatment in Preterm Newborns With Respiratory Distress Syndrome: A Single-dose, Double-blind, Random Allocation, Sham-control Clinical Trial
Led by ONY · Updated on 2025-03-30
220
Participants Needed
10
Research Sites
12 weeks
Total Duration
On this page
Sponsors
O
ONY
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Infasurf4 administered through the InfasurfAero 22, a new oral airway delivery device designed to provide Infasurf in a simpler way without needing a breathing tube or interrupting nasal respiratory support. This clinical trial focuses on preterm newborns with respiratory distress syndrome (RDS) who are stable and breathing on non-invasive nasal respiratory support. The study is a single-dose, double-blind, randomized, sham-controlled trial conducted at multiple sites. Participants will be randomly assigned to receive either a single dose of Calfactant at 6 ml/kg via the InfasurfAero 22 nebulizer or low flow respiratory air alone through the same device. The dose is given by inhalation through a pacifier interface until completion. The study compares the intervention with a sham control to assess prevention of CPAP failure and overall safety. During the study, newborns will be monitored for CPAP failure or death within the first week of age as the primary outcome. Secondary outcomes include chronic lung disease, incidence and duration of mechanical ventilation, intubation, invasive surfactant therapy, non-invasive support duration, and supplemental oxygen use up to 36 weeks post menstrual age. The total participation period and detailed follow-up assessments are designed to evaluate both safety and effectiveness thoroughly.
CONDITIONS
Brief Title
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained by parent or legal representative prior to or after birth
- Gestational age at birth between 29 0/7 and 35 6/7 weeks
- Birthweight between 1,000 and 3,500 grams
- Age between 1 and 6 hours
- Clinical diagnosis of surfactant-deficient respiratory distress syndrome, confirmed by Silverman-Anderson Retraction Score 65 5 in room air or signs of respiratory distress with radiographic confirmation
- Requires continuous positive airway pressure (CPAP)
- Respiratory Severity Score between 1.25 and 2.4
- If gestational age is greater than 34 6/7 weeks, a chest radiograph is required
You will not qualify if you...
- Surfactant administration prior to randomization
- Mechanical ventilation prior to randomization
- Major congenital anomaly, suspected or confirmed
- Airway abnormality, suspected or confirmed
- Respiratory distress due to causes other than respiratory distress syndrome (such as pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemic shock, hypoxic ischemic encephalopathy)
- Apgar score less than 3 at 5 minutes of age
- Umbilical cord gas pH less than 7.0 or base deficit greater than 10
- Any condition that the investigator believes would place the neonate at undue risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 hours after birth
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Single dose administration at enrollment
Participants receive a single dose of Infasurf administered via the InfasurfAero™ nebulizer or sham treatment through the same device.
1 treatment visit (in-person)
Duration - Up to 36 weeks post menstrual age
Participants are monitored for respiratory outcomes including CPAP failure, mechanical ventilation, and lung disease up to 36 weeks post menstrual age.
Multiple follow-up visits until 36 weeks post menstrual age
Trial Site Locations
Total: 10 locations
1
St. Josephs Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Phoenix Children's
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
Actively Recruiting
4
University of Florida -Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
5
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
6
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
7
Sisters of Charity Hospital
Buffalo, New York, United States, 14214
Actively Recruiting
8
Western TN- Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Actively Recruiting
9
Utah Valley Hospital
Provo, Utah, United States, 84604
Actively Recruiting
10
Unity Point Meriter
Madison, Wisconsin, United States, 53715
Actively Recruiting
Research Team
C
Corey Commaroto, RRT
D
Dan Swartz, PhD
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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