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

a study on Respiratory Distress Syndrome Premature Birth

Summary

Location
at UCSD
Dates
study started
study ends around

Description

Summary

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.

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

Keywords

Respiratory Distress Syndrome, Pre-term Infants, surfactant, pre-term infant, APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)

Eligibility

You can join if…

  1. Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
  2. Gestational age at birth of 26 through 33 weeks PMA
  3. Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
  4. Birth weight ≤ 2000 grams
  5. Post-natal age 1 to 24 hours at randomization
  6. 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).
  7. FiO2 ≥ 0.24 at randomization
  8. nCPAP or mPaw ≥ 6 cm H2O at randomization
  9. Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization

You CAN'T join if...

  1. On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (> 2 liters per minute [LPM]) at the time of randomization
  2. Prior instillation of surfactant
  3. Premature rupture of membranes (PROM) occurring > 14 days before birth
  4. Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
  5. Pneumothorax
  6. Other etiologies of respiratory distress
  7. Enrollment in another interventional study with similar efficacy endpoints
  8. Apgar score at 5 min of 0-3
  9. Prior cardiopulmonary resuscitation (CPR) or epinephrine
  10. 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.
  11. 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.
  12. Triplet or higher order multiple birth

Locations

  • Jacobs Medical Center accepting new patients
    La Jolla California 92037 United States
  • Christus Children's Hospital accepting new patients
    San Antonio Texas 78207 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aerogen Pharma Limited
ID
NCT06776783
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 520 study participants
Last Updated
Contact us about this trial