NCT05960929 · ONY
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
(Aero-05)
What this study is about
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel taken by mouth 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.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
Infasurf Aero™
A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
Primary outcome measures
CPAP failure and or death
Time frame: Within 1st week of age
CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) \>2.5 on two consecutive assessments at least 30 minutes apart, or an RSS \> 2.4 and one or more of the following: (i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support. (ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation). (iii) Respiratory acidosis (pCO2 \> 65 with a pH \< 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion Criteria: Inclusion criteria include ALL of the following: 1. Written informed consent obtained by parent or legal representative prior to or after birth 2. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks 3. Birthweight ≥ 1,000 AND ≤ 3,500 grams 4. Age ≥ 1 hour AND ≤ 6 hours 5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation 6. Require CPAP 7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4 8. If subject is \>346/7 weeks' gestation a chest radiograph is required Exclusion Criteria: Exclusion criteria are ANY of the following: 1. Surfactant administration prior to randomization 2. Mechanical ventilation prior to randomization 3. Major congenital anomaly (suspected or confirmed) 4. Abnormality of the airway (suspected or confirmed) 5. Respiratory distress presumed secondary to an etiology other
Where
- Phoenix, Arizona
- San Diego, California
- Jacksonville, Florida
- Honolulu, Hawaii
- Neptune City, New Jersey
- Buffalo, New York
- Jackson, Tennessee
- Provo, Utah
- Madison, Wisconsin
Collaborators
Avania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2025 · Source of record for eligibility and locations