Reading in Preterm and Full-term Children: Neural Basis and Prediction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01599546|
Recruitment Status : Active, not recruiting
First Posted : May 16, 2012
Last Update Posted : April 20, 2016
The purpose of this study is to understand reading abilities of children born preterm: their cognitive profiles, the neural basis of good and poor reading abilities, and the behavioral and neural factors that predict persistent difficulties. The investigators hope to learn
- what specific skills correlate reading skills
- if preterm children have different cognitive profiles than full term children with respect to reading
- if cognitive skills measured in kindergarten predict reading ability in the second grade
- if parts of the brain are associated with reading skill
- whether brain characteristics in kindergarten predict reading in second grade.
|Condition or disease|
|Premature Birth Basic Learning Problem in Reading Child|
On the first day we will do the following:
- We will ask your child to complete standardized tests of language, reading and intelligence.
- We will ask you child to do computerized tests about grammar and higher mental functions, such as memory and planning.
- While your child is doing tests, you will fill out some questionnaires and answer some questions about your child's health, behavior, and schooling. You may refuse to answer any individual question on the questionnaire.
- We will review your child's medical records. Medical record review is for review of previous MRI scans and other conditions that might affect your child's ability in this study.
All participants will undergo the same cognitive and academic test battery initially at age 6 and again at age 8 years old.
On the day of the MRI scanning:
- A member of the team will ask you and your child medical information to check that it is okay for your child to be tested.
- Before your child begins the study, we will ask your child if s/he has had any medications, alcohol, tobacco, or over-the-counter drugs recently. If your child is taking stimulants for Attention-Deficit/Hyperactivity Disorder or ADHD (such as Ritalin, Concerta, Dexedrine, Adderall), antihistamines, pseudoephedrine or Sudafed, we will ask you to hold these medicines 24 hours before the scan. Your child can take them after the scan is complete. Deferring stimulants for 24 hours is safe and commonly done by many children with ADHD on weekends.
- In the fMRI scanner, your child will lay on a table that slides inside the magnet. A technician will place your child's head in a head-coil (a helmet-like device) and make sure that s/he is comfortable. Your child will hold onto a ball that sounds an alarm when squeezed. This is a signal for the technician to stop the scan, come in to talk with your child, and take him or her out of the scanner if s/he is unable to continue with the tests. We will take pictures of the structure of your child's brain. During this time s/he can watch part of a video of his/her choice or one from our video library. In order for the brain pictures to come out right, it is very important that s/he does not move her/his head while inside the scanner. In between tasks, the technician will talk to your child through a microphone and ask if everything is OK. Your child should respond in a loud, clear voice without moving his/her head. We hope your child can complete the testing. Your child can choose to stop the testing at any time s/he needs to. Your child should tell the technician if anything is uncomfortable. You may sit in the scanning room if your child wants you to and if you don't have any metal in your body or any other MRI exclusions.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Reading in Preterm and Full-term Children: Neural Basis and Prediction|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2020|
Full Term children
born >36 weeks, currently age 6 +/- 6 months
born <35 weeks, age 6 +/- 6 months at the beginning of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599546
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Heidi M Feldman, MD PhD||Stanford University|