Hyperbilirubinemia, Neonatal
Conditions
Keywords
stannsoporfin
Brief summary
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.
Detailed description
Outcomes will be based on the following variables: Reported AEs and SAEs Hearing assessments Developmental assessments
Interventions
DRUGStannsoporfin
Stannsoporfin administered by intramuscular (IM) injection
DRUGPlacebo
Matching placebo administered by IM injection
Sponsors
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Days to 52 Months
Healthy volunteers
No
Inclusion criteria
* Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204 * Parents or guardians have given written informed consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reported adverse events (AEs) | 48-52 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing assessments | 48 - 52 month | Conventional audiometry will be performed by a qualified specialist. Any findings from a failed conventional audiology examination will be recorded |
| Developmental assessments | 48 - 52 month | 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. |
Outcome results
None listed