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Recruiting NCT06776783

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

Phase III Interventional Respiratory Distress Syndrome Pre-term Infants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system), Control.
Who it may be relevant to
Registry conditions: Respiratory Distress Syndrome, Pre-term Infants. Basic parameters: 1 Hour — 24 Hours · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Combination product APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)
    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.
  • Other Control
    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 outcome measures

  • Failure Criteria [Time frame: First 7 days of life]
Secondary outcome measures (3)
  • Instilled Bolus Surfactant [Time frame: First 72 hours of life]
  • Multiple Bolus Surfactant Doses [Time frame: First 72 hours of life]
  • Total Number of Bolus Surfactant Doses [Time frame: First 72 hours of life]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 12 centers
  • University of Arkansas for Medical Sciences — Little Rock
  • Jacobs Medical Center — La Jolla
  • UF Health Jacksonville — Jacksonville
  • Advent Health — Orlando
  • Memorial Hospital of South Bend — South Bend
  • Goryeb Children's Hospital — Morristown
  • The Trustees of Columbia University in the City of New York — New York
  • Montefiore Medical Center — The Bronx
  • … and 4 more centers

Identifiers

NCT: NCT06776783 · APC-AF-CLN-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗