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NCT Number: NCT06776783

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

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.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Pre-term Infants Respiration Disorders Respiratory Tract Diseases

Age range

1 hour–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)

Combination Product

Subjects in the APC-0101 group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface and APC-0101 treatment will be started.

Control

Other

Subjects in the Control group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface but an empty vial will be used instead of APC-0101.

Primary outcomes

  1. Failure Criteria

    Time frame: First 7 days of life

    Number (%) of subjects who meet the predetermined criteria for failure of nCPAP/NIV

Secondary outcomes

  1. Instilled Bolus Surfactant

    Time frame: First 72 hours of life

    The number (%) of subjects in each group who receive instilled bolus surfactant.

  2. Multiple Bolus Surfactant Doses

    Time frame: First 72 hours of life

    The number (%) of subjects in each group who receive multiple doses of bolus surfactant.

  3. Total Number of Bolus Surfactant Doses

    Time frame: First 72 hours of life

    The total number of bolus doses of surfactant received per subject in each group.

Study contacts

Contact information is provided by the study sponsor or research team.

Shannon Strom

CONTACT

[email protected]

9196026411

Sponsors and collaborators

Lead sponsor

Aerogen Pharma Limited

Industry

Registry information

Official study title

A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of APC-0101 (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jan 15, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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