Bronchopulmonary Dysplasia
Conditions
Keywords
Bronchopulmonary Dysplasia, Preterm, Neonate, Mechanical ventilation, Respiratory support, recombinant human Surfactant Protein-D (rhSP-D), intratracheal, air-sham
Brief summary
The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham alone.
Interventions
Sponsors
Airway Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Phase 1b portion is a randomized, dual-armed, dose escalation study to establish the safest & most tolerated AT-100 dose tested as compared to air-sham alone.
Eligibility
Sex/Gender
ALL
Age
0 Minutes to 96 Hours
Healthy volunteers
No
Inclusion criteria
1. Preterm neonates born between Gestional Age (GA): 1. 25 0/7 weeks to 28 6/7 weeks in the initial dose escalation cohorts. 2. 23 0/7 weeks to 28 6/7 weeks in the latter cohort. 2. Intubated and on mechanical ventilation. 3. Receiving at least 1 dose of standard-of-care-indicated surfactant treatment (Curosurf®) after birth, and able to receive the first dose of AT-100 or air-sham within 96 hours of birth given at any time point after 15 minutes following any of the subject's Curosurf® dose(s). 4. Parent or legal guardian is able to provide informed consent.
Exclusion criteria
1. Weight at time of birth \< 400 g or \> 1,800 g. 2. Major apparent congenital abnormalities impacting cardio and pulmonary function. 3. Active DNR (Do Not Resuscitate) order in place. 4. Known pulmonary air leaks (e.g. pneumothorax and pneumomediastinum) at the time of AT-100 or air-sham administration. 5. History of allergy or sensitivity to any surfactant or any component of the Investigational Product (AT-100). 6. AT-100 or air-sham dosing was set to occur before Data Safety Monitoring Committee recommendation to proceed to the next dose-escalation cohort. 7. Use of minimally invasive surfactant techniques (e.g., LISA, MIST) or INSURE or if, in the opinion of the care team, the infant is very likely too be extubated shortly after receiving Curosurf®. a. Subjects extubated and re-intubated after their Curosurf® dose(s) are eligible, so long as the subject meets Inclusion #3. 8. Birth mother: 1. Has known active Hepatitis B, C, or E diagnosis. 2. Has a known illness or exposure that, in the judgement of the Investigator, is serious enough to induce an immune deficiency such as Human Immunodeficiency Virus (HIV) and/or is receiving chemotherapy. 3. Has known active Sexually Transmitted Infection (STI). 4. Has known Cytomegalovirus (CMV) active infection. 5. Has known history or evidence of alcohol or drug abuse, wit the exception of marijuana/marijuana-based products/THC, based on a positive maternal or infant drug screen as evidenced by the institution's standard-of-care practice. 9. Concurrent enrollment in an investigational drug, device, or treatment modulation trial that utilizes treatments outside of standard-of-care. 10. Any condition or situation which, in the Investigator's judgement, puts the mother or the neonate at significant risk, could confound the trial results, or may interfere significantly with the mother's or neonate's participation in the trial. 11. Symptomatic and confirmed COVID-19 infection of the mother around the time of birth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events | Adverse events will be followed up to Day 28 of life | Incidence and severity of adverse events between the two treatment groups will be compared |
| Incidence of BPD or death | Week 36 PMA | — |
Countries
Spain, United States
Outcome results
None listed