Premature BirthNCT01599546
Reading in Preterm and Full-term Children: Neural Basis and Prediction
An observational study of Premature Birth and Basic Learning Problem in Reading, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 57 to 78 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Basic Learning Problem in Reading, Child
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 57 to 78 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born <35 weeks (preterm) as compared to >36 weeks (full-term)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Premature Birth, Basic Learning Problem in Reading, Child
- Keywords
- Preterm, Full term, Reading, Dyslexia, Brain, Diffusion tensor imaging
- Medical subject headings
- Premature Birth, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJan 2012
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi M. Feldman, Stanford University
- Investigators
- Heidi M Feldman, MD PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599546
- Sponsor's protocol ID
- IRB-22233
- Status last verified
- Apr 2018
- First submitted
- 14 May 2012
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reading in Preterm and Full-term Children: Neural Basis and Prediction
- ClinicalTrials.gov ID
- NCT01599546
- Acronym / sponsor ID
- IRB-22233
- Conditions
- Premature Birth, Basic Learning Problem in Reading, Child
- Keywords
- Preterm, Full term, Reading, Dyslexia, Brain, Diffusion tensor imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 57 to 78 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born <35 weeks (preterm) as compared to >36 weeks (full-term)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Stanford Center for Cognitive and Neurobiological ImagingLink provided by the sponsor.
Related trials for Premature Birth
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Maximising Maternal Milk for Preterm Infant
Breastfeeding, Prematurity
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi M Feldman, MD PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Basic Learning Problem in Reading, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.