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RecruitingPhase 3

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

ONY · with Avania · NCT05960929

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 7 mo–8 mo · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
220
US sites recruiting
10
Study start
January 1, 2025
Record last updated
March 30, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Infasurf Aero™

Conditions: Respiratory Distress Syndrome (Neonatal); Intubation Complication; Death; Neonatal

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Inclusion 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 confirmation
  • 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

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 encephalopathy)
  • Apgar score \< 3 at 5 minutes of age
  • Umbilical cord gas pH \<7.0 or BD > 10
  • Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Recruiting US locations

  • St. Josephs Hospital and Medical Center

    Phoenix, AZ 85013

    Site contact: Serena Stewart · (602) 406-3000 · serena.stewart@commonspirit.org

  • Phoenix Children's

    Phoenix, AZ 85016

    Site contact: Kathie Laitano · 602-933-1000 · klaitano@phoenixchildrens.com

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, CA 92123

    Site contact: Alona Diem · 858-939-4301 · Alona.Diem@sharp.com]

  • University of Florida -Jacksonville

    Jacksonville, FL 32209

    Site contact: Kimberly Barnett · (904) 244-0411 · kimberly.barnette@jax.ufl.edu

  • Kapi'olani Medical Center for Women & Children

    Honolulu, HI 96826

    Site contact: micah Tong · (808) 983-6000 · micah.tong@hawaiipacifichealth.org

  • Jersey Shore University Medical Center

    Neptune City, NJ 07753

    Site contact: Chris DeBari · 1-732-775-5500 · christopher.debari@hmhn.org

  • Sisters of Charity Hospital

    Buffalo, NY 14214

    Site contact: George Albert, MD · 716-862-1000

  • Western TN- Jackson-Madison County General Hospital

    Jackson, TN 38301

    Site contact: Laura Choate, BSN · (731) 541-5000 · laura.choate@wth.org

  • Utah Valley Hospital

    Provo, UT 84604

    Site contact: Jennifer Elmont · 801-507-7036 · Jennifer.Elmont@imail.org

  • Unity Point Meriter

    Madison, WI 53715

    Site contact: Shayla Schwingle Study Coordinator · (608) 417-6000 · snschwingle@wisc.edu

Study contacts (from the official record)

  • Corey Commaroto, RRT · 7163614659 · ccommaroto@onybiotech.com
  • Dan Swartz, PhD · 716428-3132 · dswartz@onybiotech.com
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InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (NCT05960929) | Bored Studies