Infant Developmental Assessment
Conditions
Keywords
post-natal monitoring, exposure in utero
Brief summary
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
Detailed description
This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.
Interventions
OTHERUnintentional exposure in utero
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Months
Healthy volunteers
No
Inclusion criteria
Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bayley Infant Neurodevelopmental Screener | 0-2 Months |
| Receptive-Expressive Emergent Language Test | 0-2 Months |
Countries
United States
Outcome results
None listed