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The Natural History of Spina Bifida in Children Pilot Project-New-National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Spina Bifida (SB) is one of the most common birth defects, affecting approximately 2 per 10,000 live births in the United States annually. To date, there are no U.S. population-based cohort studies or programs on the natural history of SB. This is of importance because persons with SB often experience condition-specific difficulties and secondary conditions that detrimentally affect several aspects of their lives. The long-term purpose of this project is to increase the knowledge about the natural history of Spina Bifida by prospectively studying children who were born with this potentially disabling condition. We estimate to enroll approximately 40 parents with a child with Spina Bifida ages 3-, 4-, or 5-years of age, and 20 of the children of these forty parents. The data to be collected will relate to medical concerns prevalent among individuals with Spina Bifida in the areas of neurology/neurosurgery, urology, and orthopedics; development and learning; nutrition and physical growth; mobility and functioning; general health; and family demographics. Families interested in participating can choose between participating in a phone survey (no more than 45 minutes) or an in-person assessment (no more than 3 hrs). For families who participate in the in-person assessment (estimated to be twenty of the forty families), the child will also be invited to participate in a child-appropriate assessment.
Data will also be collected on the actual recruitment process. Results from the project will be evaluated and disseminated to provide guidance for states that are interested in following children with Spina Bifida prospectively. The proposed project is the initial step to document the development, the health status, and the onset of complications among children with SB in order that effective interventions may be identified that will ameliorate the course of this complex, multi-system condition. Long-term results will help determine if it would be beneficial to systematically screen children with Spina Bifida for certain health-related educational and developmental problems that these children are at an increased risk of experiencing and at what age such a screening should be performed.
There will be no cost to the respondents other than their time. The total estimated annualized burden hours are 97.
|Respondents||Number of respondents||Number of responses per respondent||Average burden per response (in hours)|
|Parents (phone survey)||20||1||45/60|
|Parents (in-person assessment)||20||1||2.5|
|Child (in-person assessment)||20||1||1.5|
|SB Clinic Coordinator (recruitment effort)||1||1||2|
Dated: August 22, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E8-19968 Filed 8-27-08; 8:45 am]
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