InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
ONY
Study ID
NCT05960929
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
29 Weeks - 36 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Infasurf Aero™ — COMBINATION_PRODUCT
    A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Nov 2024
Primary completion
Jan 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.
  • Sham Comparator: Control Arm
    Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.

Primary Outcome Measure

CPAP failure and or death [ Time Frame: Within 1st week of age ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Phoenix Children'sPhoenixArizona85016
Kathie Laitano
[email protected]
602-933-1000
Greg Martin, MD (PRINCIPAL_INVESTIGATOR)
St. Josephs Hospital and Medical CenterPhoenixArizona85013
Serena Stewart
[email protected]
(602) 406-3000
mohammed Elkhwad, MD (PRINCIPAL_INVESTIGATOR)
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123
Alona Diem
[email protected]]
858-939-4301
Anup Katheria, MD (PRINCIPAL_INVESTIGATOR)
University of Florida -JacksonvilleJacksonvilleFlorida32209
Kimberly Barnett
[email protected]
(904) 244-0411
Henry Zapata Galarza, MD (PRINCIPAL_INVESTIGATOR)
Kapi'olani Medical Center for Women & ChildrenHonoluluHawaii96826
micah Tong
[email protected]
(808) 983-6000
Sheri Kuo, MD (PRINCIPAL_INVESTIGATOR)
Jersey Shore University Medical CenterNeptune CityNew Jersey07753
Chris DeBari
[email protected]
1-732-775-5500
Ann Ross, MD (PRINCIPAL_INVESTIGATOR)
Sisters of Charity HospitalBuffaloNew York14214
George Albert, MD
716-862-1000
George Albert, MD (PRINCIPAL_INVESTIGATOR)
Western TN- Jackson-Madison County General HospitalJacksonTennessee38301
Laura Choate, BSN
[email protected]
(731) 541-5000
Scott Guthrie, MD (SUB_INVESTIGATOR)
Stacy Slagle, MD (PRINCIPAL_INVESTIGATOR)
Utah Valley HospitalProvoUtah84604
Jennifer Elmont
[email protected]
801-507-7036
Steven Minton, MD (PRINCIPAL_INVESTIGATOR)
Erick Gerday, MD (PRINCIPAL_INVESTIGATOR)
Unity Point MeriterMadisonWisconsin53715
Shayla Schwingle Study Coordinator
[email protected]
(608) 417-6000
Dinushuan Kaluarachchi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's· Phoenix, AZSt. Josephs Hospital and Medical Center· Phoenix, AZSharp Mary Birch Hospital for Women & Newborns· San Diego, CAUniversity of Florida -Jacksonville· Jacksonville, FLKapi'olani Medical Center for Women & Children· Honolulu, HIJersey Shore University Medical Center· Neptune City, NJ

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