Orlando, FLNCT06776783Now EnrollingIRB Ready

Respiratory Distress Syndrome Clinical Trial in Orlando, FL

Access cutting-edge respiratory distress syndrome treatment through this clinical trial at a research site in Orlando. Study-provided care at no cost to qualified participants.

Sponsored by Aerogen Pharma Limited

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Expert Care in Orlando

Access respiratory distress syndrome specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related respiratory distress syndrome treatment provided free

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Check if you qualify for this respiratory distress syndrome clinical trial in Orlando, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Orlando

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Orlando site if eligible
  4. 4Begin participation

About This Respiratory Distress Syndrome Study in Orlando

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.

Sponsor: Aerogen Pharma Limited

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT06776783) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Respiratory Distress Syndrome Treatment Options in Orlando, FL

If you're searching for respiratory distress syndrome treatment options in Orlando, FL, this clinical trial (NCT06776783) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this clinical trial. You'll receive care from experienced respiratory distress syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all respiratory distress syndrome clinical trials near you to find additional studies recruiting in your area.

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