RECRUITING

InfasurfAero™ Versus Sham Treatment in Preterm Newborns with RDS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

InfasurfAero™ Versus Sham Treatment in Preterm Newborns with RDS: a Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial

Quick Facts

Study Start:2025-01-01
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05960929

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:29 Weeks to 36 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Written informed consent obtained by parent or legal representative prior to or after birth
  2. 2. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
  3. 3. Birthweight ≥ 1,000 AND ≤ 3,500 grams
  4. 4. Age ≥ 1 hour AND ≤ 6 hours
  5. 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. 6. Require CPAP
  7. 7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
  8. 8. If subject is \>346/7 weeks' gestation a chest radiograph is required
  1. 1. Surfactant administration prior to randomization
  2. 2. Mechanical ventilation prior to randomization
  3. 3. Major congenital anomaly (suspected or confirmed)
  4. 4. Abnormality of the airway (suspected or confirmed)
  5. 5. 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)
  6. 6. Apgar score \< 3 at 5 minutes of age
  7. 7. Umbilical cord gas pH \<7.0 or BD \> 10
  8. 8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Contacts and Locations

Study Contact

Corey Commaroto, RRT
CONTACT
7163614659
ccommaroto@onybiotech.com
Dan Swartz, PhD
CONTACT
716428-3132
dswartz@onybiotech.com

Principal Investigator

Scott Guthrie, MD
STUDY_CHAIR
Vanderbilt Jackson-Madison, Jackson TN
Dinushan Kaluarachchi, MD
STUDY_CHAIR
Unity Point Meriter, Madison WI
Jim Cummings, MD
STUDY_DIRECTOR
Ony Biotech

Study Locations (Sites)

St. Josephs Hospital and Medical Center
Phoenix, Arizona, 85013
United States
Phoenix Children's
Phoenix, Arizona, 85016
United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
United States
University of Florida -Jacksonville
Jacksonville, Florida, 32209
United States
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, 96826
United States
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
United States
Sisters of Charity Hospital
Buffalo, New York, 14214
United States
Western TN- Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
United States
Utah Valley Hospital
Provo, Utah, 84604
United States
Unity Point Meriter
Madison, Wisconsin, 53715
United States

Collaborators and Investigators

Sponsor: ONY

  • Scott Guthrie, MD, STUDY_CHAIR, Vanderbilt Jackson-Madison, Jackson TN
  • Dinushan Kaluarachchi, MD, STUDY_CHAIR, Unity Point Meriter, Madison WI
  • Jim Cummings, MD, STUDY_DIRECTOR, Ony Biotech

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

  • Infasurf
  • Calfactant
  • Inhalation
  • Nebulization
  • Preterm
  • InfasurfAero
  • Respiratory Distress Syndrome
  • Neonatal
  • NICU
  • CPAP
  • Intubation
  • Aerosol
  • CPAP Failure

Additional Relevant MeSH Terms

  • Respiratory Distress Syndrome (Neonatal)
  • Intubation Complication
  • Death; Neonatal