Kicking Behavior in Infants with Spina Bifida following in Utero and Postnatal Surgery
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-005714
Sponsor Protocol Number: 15-005714
About this study
The aim of this study is to describe how kicking frequency and complexity differs over developmental time between typically developing infants, infants with SB who have had prenatal repair of their spinal lesion, and infants with SB who have had postnatal repair.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
(SB) = Spina bifida | TD = typically developing)
- (SB) Infant with lumbar or sacral spina bifida (upper boundary of myelomeningocele located between L1 and S4).
- (SB) Equal numbers of participants who have qualified for or received prenatal and postnatal surgery.
- (SB, TD) Live within a 300-mile radius.
- (SB, TD) Infant age < one year.
Exclusion Criteria:
- Infants with thoracic or higher spinal lesions.
- Infants who are older than one year.
- Infants with congenital heart defects.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kristin Zhao, Ph.D., M.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available