Actively Recruiting
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
Led by ONY · Updated on 2025-03-30
220
Participants Needed
10
Research Sites
65 weeks
Total Duration
On this page
Sponsors
O
ONY
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.
CONDITIONS
Official 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 29 29 0/7 and 29 35 6/7 weeks
- Birthweight 29 1,000 and 29 3,500 grams
- Age 29 1 hour and 29 6 hours
- Clinical diagnosis of surfactant-deficient RDS with either Silverman-Anderson Retraction Score 29 5 in room air or signs of respiratory distress plus radiographic confirmation
- Require continuous positive airway pressure (CPAP)
- Respiratory Severity Score (RSS) 29 1.25 and 29 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)
- Abnormality of the airway (suspected or confirmed)
- Respiratory distress due to causes other than RDS (e.g., 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 places the neonate at undue risk according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
D
Dan Swartz, PhD
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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