Neonatology: Clinical Studies Open For Enrollment
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Eligibility
- 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 (260/7 through 336/7 weeks PMA)
- Birth weight appropriate for gestational age (AGA; weight 3rd to 97thpercentile 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 respiratory severity score (RSS) = 1.4 – 2.0 to maintain SpO2 90-95%. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).
- FiO2 ≥ 0.24 at randomization
- nCPAP or mean airway pressure (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. These support systems are excluded because they cannot interface with the AeroFact system and/or do not provide accurate measurement of nCPAP level.
- 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 primary efficacy endpoints
- Apgar score at 5 minutes after birth of 0-3
- Prior cardiopulmonary resuscitation (CPR) or epinephrine
- Base Deficit > 15 mEq/L on most recent arterial blood gas (ABG; not capillary blood gas, venous blood gas, or cord gas) prior to randomization, if available. Note that ABG is not a required procedure prior to randomization.
- Partial pressure of carbon dioxide (PaCO2) > 65 mmHg on most recent AGB (not capillary blood gas, venous blood gas, or cord gas) prior to randomization, if available. Note that AGB is not a required procedure prior to randomization.
- Triplet or higher order multiple birth.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06776783
Principal Investigator
Edmund F La Gamma, MD
Contact for Study Screening