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Tests treatment safety and results for Respiratory Distress Syndrome
Official title Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
ClinicalTrials.gov ID: NCT06776783
What this study is testing
What is APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)?
APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) is an investigational medicine, being studied as a potential treatment for respiratory distress syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 24
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 treatment study with similar how well it works 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
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- South Bend, Indiana, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- The Bronx, New York, United States
- Valhalla, New York, United States
- San Antonio, Texas, United States
- Charlottesville, Virginia, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 hour to 24 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; La Jolla, California, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; South Bend, Indiana, United States; Morristown, New Jersey, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.