The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.
Outcomes will be based on the following variables: Reported AEs and SAEs Hearing assessments Developmental assessments
Study Type
OBSERVATIONAL
Enrollment
68
Stannsoporfin administered by intramuscular (IM) injection
Matching placebo administered by IM injection
Reported adverse events (AEs)
Time frame: 48-52 month
Hearing assessments
Conventional audiometry will be performed by a qualified specialist. Any findings from a failed conventional audiology examination will be recorded
Time frame: 48 - 52 month
Developmental assessments
The Mullen Scales of Early Learning examination has been selected for its standardized measurement of developmental skills in multiple domains (gross motor, visual reception, fine motor, expressive language, and receptive language). Testing will be done at visits 1 and 2 by a healthcare individual trained to administer the test. The Mullen raw scores, T-scores, and age equivalents will be recorded.
Time frame: 48 - 52 month
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