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Compares treatment options for Respiratory Distress Syndrome (Neonatal)
Official title InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
ClinicalTrials.gov ID: NCT05960929
What this study is testing
What is Infasurf Aero™?
Infasurf Aero™ is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for respiratory distress syndrome (neonatal).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 29 to 36
You may be able to join if
- include ALL of the following:
- Written informed consent obtained by parent or legal representative prior to or after birth
- Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
- Birthweight ≥ 1,000 AND ≤ 3,500 grams
- Age ≥ 1 hour AND ≤ 6 hours
You likely can't join if
- Exclusion criteria are ANY of the following:
- 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 presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration...
See the full eligibility criteria
- include ALL of the following:
- Written informed consent obtained by parent or legal representative prior to or after birth
- Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
- Birthweight ≥ 1,000 AND ≤ 3,500 grams
- Age ≥ 1 hour AND ≤ 6 hours
- 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...
- Require CPAP
- Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
- If subject is \>346/7 weeks' gestation a chest radiograph is required
- Exclusion criteria are ANY of the following:
- 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 presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic...
- Apgar score \< 3 at 5 minutes of age
- Umbilical cord gas pH \ 10
- Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- San Diego, California, United States
- Jacksonville, Florida, United States
- Honolulu, Hawaii, United States
- Neptune City, New Jersey, United States
- Buffalo, New York, United States
- Jackson, Tennessee, United States
- Provo, Utah, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 29 weeks to 36 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; San Diego, California, United States; Jacksonville, Florida, United States; Honolulu, Hawaii, United States; Neptune City, New Jersey, United States; Buffalo, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.