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RecruitingPhase 3

Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome

Aerogen Pharma Limited · NCT06776783

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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
Any age listed · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
520
US sites recruiting
18
Study start
September 24, 2025
Record last updated
October 13, 2026

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

What the study is about

This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.

Being studied: APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system); Control

Conditions: Respiratory Distress Syndrome; Pre-term Infants

Eligibility criteria

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

Show full criteria

Inclusion Criteria

  • Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
  • Gestational age at birth of 26 through 33 weeks PMA
  • Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
  • Birth weight ≤ 2000 grams
  • Post-natal age 1 to 24 hours at randomization
  • On nCPAP or NIV for at least 30 minutes with RSS = 1.4 - 2.0 to maintain SpO2 90-95% at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).
  • FiO2 ≥ 0.24 at randomization
  • nCPAP or mPaw ≥ 6 cm H2O at randomization
  • Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization

Exclusion Criteria

  • On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (> 2 liters per minute [LPM]) at the time of randomization
  • Prior instillation of surfactant
  • Premature rupture of membranes (PROM) occurring > 14 days before birth
  • Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
  • Pneumothorax
  • Other etiologies of respiratory distress
  • Enrollment in another interventional study with similar efficacy endpoints
  • Apgar score at 5 min of 0-3
  • Prior cardiopulmonary resuscitation (CPR) or epinephrine
  • Base Deficit > 15 mEq/L on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.
  • Partial pressure of carbon dioxide (PaCO2) > 65 mmHg on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization.
  • Triplet or higher order multiple birth

Recruiting US locations

  • University of Arkansas for Medical Sciences

    Little Rock, AR 72205

    Site contact: Vonita Chawla, MD · 501-364-1028 · vchawla@uams.edu

  • Jacobs Medical Center

    La Jolla, CA 92037

    Site contact: Sarah Lazar, MPH · 858-249-1711 · NICUstudies@health.ucsd.edu

  • University of California Davis Children's Hospital

    Sacramento, CA 95817

    Site contact: Akina Shimizu · 916-734-3125 · ashimizu@health.ucdavis.edu

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, CA 92123

    Site contact: Anup Katheria · 858-939-6307 · anup.katheria@sharp.com

  • UF Health Jacksonville

    Jacksonville, FL 32209

    Site contact: Megan Mathews · 904-244-5450 · megan.mathews@ufhealth.org

  • Advent Health

    Orlando, FL 32803

    Site contact: Narendra Dereddy, MD · 407-609-3280 · Narendra.Dereddy.MD@adventhealth.com

  • Memorial Hospital of South Bend

    South Bend, IN 46601

    Site contact: Amber Wallace · 574-647-7141 · awallace@beaconhealthsystem.org

  • University of Maryland Children's Hospital

    Baltimore, MD 21201

    Site contact: Lisa Brengle · 410-706-1422 · lbrengle@som.umaryland.edu

  • Tufts Medical Center

    Boston, MA 02111

    Site contact: Juliet Ali-Caccamo · 617-636-2393 · j.ali-caccamo@tuftsmedicalcenter.org

  • Goryeb Children's Hospital

    Morristown, NJ 07960

    Site contact: John Ladino, MD · 973-971-5488 · John.Ladino@atlantichealth.org

  • Mount Sinai Hospital

    New York, NY 10024

    Site contact: Courtney Juliano, MD · 212-241-6936 · courtney.juliano@mssm.edu

  • The Trustees of Columbia University in the City of New York

    New York, NY 10032

    Site contact: Rakesh Sahni, MD · 212-305-8500 · r262@cumc.columbia.edu

  • Montefiore Medical Center

    The Bronx, NY 10461

    Site contact: Ibadete Xama, MBA · Ibadete.xama@einsteinmed.edu

  • Maria Farreri Children's Hospital

    Valhalla, NY 10595

    Site contact: Edmund F LaGamma, MD · 914-493-8558 · edmund_lagamma@nymc.edu

  • University of Pittsburgh Medical Center Magee Women's Hospital

    Pittsburgh, PA 15213

    Site contact: Emma Cribbs · 412-692-7750 · cribbsel@upmc.edu

  • Christus Children's Hospital

    San Antonio, TX 78207

    Site contact: Terri Newsom · 210-704-2823 · Terriel.newsom@christushealth.org

  • University of Virginia Children's Hospital

    Charlottesville, VA 22903

    Site contact: Heeju Yang, CCRP · 434-529-0304 · hvw8cy@uvahealth.org

  • WVU Medicine Children's Hospital

    Morgantown, WV 26506

    Site contact: Mark Polak, MD, PhD · 304-293-1202 · mpolak@hsc.wvu.edu

Study contacts (from the official record)

  • Medical Director · 9196026411 · AF3inquiries@aerogenpharma.com
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Safety and Efficacy of APC-0101 in Preterm Infants With… (NCT06776783) | Bored Studies