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โ† Trials
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Safety, PK and PD of FLQ-101 in Premature Neonates

RecruitingPhase 1Ages 4 Days - 5 DaysAllFELIQS INC.
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Written consent is obtained from parent(s) or legal guardian. * Neonates born at 25 weeks +0 days and 27 weeks +6 days of gestation. Exclusion Criteria: * Neonates with congenital malformation of the eye or any other ocular condition that may prevent or relevantly affect any of the assessments or procedures. * Neonates with serious congenital anomalies, severe congenital infection, and chromosomal abnormalities. * Neonates who are seriously ill and not expected to survive. * Neonates with heart disease, including cardiomyopathy, serious arrhythmias, and congenital heart disease. (Neonates with patent foramen ovale may be included in the study if clinically stable). * Neonates that are small for gestational age defined as having a weight \<10th percentile at birth based on the Fenton growth charts for gestational age and sex. * Neonates with history of or ongoing intraventricular hemorrhage (IVH) grades 2, 3 or 4. Neonates with IVH grade 1 may be included in the study at the discretion of the PI. * Neonates with any other medical conditions or clinically significant comorbidities or circumstances that in the opinion of the investigator may have a relevant impact on study participation or any of the study assessments or procedures. * Infants scheduled to participate in other interventional clinical trials while participating in the study and until reaching end of study.
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What it tests

  • FLQ-101
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Where

1 site
St. David's Medical Center
Austin, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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