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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Heidi M. Feldman, Stanford University
ClinicalTrials.gov Identifier:
NCT01599546
First received: May 14, 2012
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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
Premature Birth
Basic Learning Problem in Reading
Child

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Stanford University:

Estimated Enrollment: 100
Study Start Date: January 2012
Groups/Cohorts
Full Term children
born >36 weeks, currently age 6 +/- 6 months
Preterm children
born <35 weeks, age 6 +/- 6 months at the beginning of the study.

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.
  Eligibility

Ages Eligible for Study:   57 Months to 78 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children born <35 weeks (preterm) as compared to >36 weeks (full-term)

Criteria

Inclusion Criteria:

  • Pre-terms: PT children born <35 weeks gestation and weighing <2000 grams at birth.
  • Full-term: FT participants will be healthy children born ≥ 36 weeks gestation and weighing ≥ 2750 grams, who are developing typically per pediatrician well-visit report and match the PT group on age, gender, and SES.

Exclusion Criteria:

  • Congenital anomalies or recognizable malformation syndromes
  • Mother's self-reported use of illicit drugs or alcohol during pregnancy;
  • Birth weight <3rd %tile (small for gestational age, SGA) according to gestational age specific growth curves;
  • Serious neurological problems including active seizure disorder (afebrile seizure within the last year) and/or anticonvulsant medication use, history of a central nervous system infections, or ventriculoperitoneal shunt for treatment for hydrocephalus
  • IQ < 70 on the testing of this study because we would expect language delays in this group;
  • Sensori-neural hearing loss, defined as 4-tone pure-tone average > 25 decibels as assessed at any time because hearing loss compromises language and reading development;
  • Visual impairments that would interfere with the ability to read; (8) presence of any other health condition that might compromise academic functioning (FT only).
  • Any child who has not been learning English either at home or at school for at least 2 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599546

Contacts
Contact: Vanessa N Durand, BA 650-498-7690 vndurand@stanford.edu
Contact: Heidi M Feldman, MD PhD 650-723-5711 hfeldman@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Heidi M Feldman, MD PhD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Heidi M. Feldman, MD, PhD, Stanford University
ClinicalTrials.gov Identifier: NCT01599546     History of Changes
Other Study ID Numbers: IRB-22233
Study First Received: May 14, 2012
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Preterm
Full term
Reading
Dyslexia
Brain
Diffusion tensor imaging

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on November 20, 2014