Stopped: As the revised OHB-607-202 protocol extends the study's observational arm through 24 months corrective age (CA), the SHP607-203 protocol was terminated at 24 months CA.
The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.
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Number of Emergency Room Visits
Timeframe: 12 months CA through 60 months CA
Number of Hospitalizations
Timeframe: 12 months CA through 60 months CA
Incidence of Signs and Symptoms of Respiratory Disease
Timeframe: 12 months CA through 60 months CA
Number of Days of Respiratory Medication Use
Timeframe: 12 months CA through 60 months CA
Total Number of Days on Home Respiratory Technology use
Timeframe: 12 months CA through 60 months CA
Number of Participants With Adverse Events (AEs)
Timeframe: 12 months CA through 60 months CA