Clinical Trials Directory

Trials / Completed

CompletedNCT01599546

Reading in Preterm and Full-term Children: Neural Basis and Prediction

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
57 Months – 78 Months
Healthy volunteers
Accepted

Summary

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.

Detailed description

On the first day we will do the following: 1. We will ask your child to complete standardized tests of language, reading and intelligence. 2. We will ask you child to do computerized tests about grammar and higher mental functions, such as memory and planning. 3. 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. 4. 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: 1. 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. 2. 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. 3. 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.

Conditions

Timeline

Start date
2012-01-01
Primary completion
2017-06-30
Completion
2017-06-30
First posted
2012-05-16
Last updated
2018-04-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01599546. Inclusion in this directory is not an endorsement.