Language DevelopmentNCT01599780
Language Development in Preterm Children
An observational study of Language Development, run by Stanford University at 1 site in United States.
Trial summary
This research investigates the ways in which preterm birth affects how very young children learn to speak and understand language, and how older children gain efficiency in language processing. Read more about this study
- Who is it for?
- Ages Up to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to 28 Feb 2018
- 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 Up to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born <33 weeks gestation (preterm)
Who may be able to join
- <33 weeks gestation
- <1800 grams at birth
- currently ≤ 18 months
Who cannot join
- an active seizure disorder (afebrile seizure within the last year) and/or anticonvulsant medication use
- central nervous system infections, revisions or other complications of a ventriculoperitoneal shunt for treatment for hydrocephalus, and/or congenital malformations
- history of a sensori-neural hearing loss, defined as 4-tone pure-tone average > 25 decibels
- visual impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: On- and Off-line Measures of Language Development in Preterm Children
This research investigates the ways in which preterm birth affects how very young children learn to speak and understand language, and how older children gain efficiency in language processing. The investigators observe how children at different ages learn new words and comprehend familiar words, how they communicate effectively with others, and how they use both linguistic and non-linguistic skills in problem-solving. All of the activities in the investigators' studies are designed to be age-appropriate and fun for children.
Read the detailed description
In a typical session, the investigators video-record your child participating in one or more engaging activities with you and/or a member of the staff.
- In one type of task, your child looks at colorful pictures on a video screen while listening to recorded speech referring to the pictures. The investigators may vary factors in the speech stimuli such as word familiarity or sentence structure to learn more about the development of language understanding. Your child is seated on your lap throughout the session. From the video record, the investigators can later look at your child's gaze patterns in response to speech.
- In another type of task, the investigators observe children interacting with a staff member in the playroom. In these game-like activities, your child may be asked to play with toys, name or point to pictures, repeat sequences of words or sentences, tell stories, imitate hand movements, or solve puzzles. These observations help the investigators understand how language development relates to other types of cognitive activities in children at different ages.
- In a third type of task, the investigators observe how children interact spontaneously in a less structured situation. In some cases, the investigators observe you as you play with your child in a playroom. The investigators will provide you with a selection of toys appropriate to your child's age, and ask you to engage with your child as you would at home. From these observations, the investigators learn how children at different ages respond to language in the context of social interaction.
The investigators may also collect a language questionnaire and similar forms containing basic information about your child's development. Additionally, the investigators may review your child's medical records, including ultrasounds and MRI scans, to gain a better understanding of your child's medical history. All information is used for purposes of basic research on language learning only, and will not constitute a clinical assessment or evaluation.
TIME INVOLVEMENT
In this longitudinal study, each child is expected to come for a total of 12-16 sessions of behavioral testing, spread out over 3 years. Children are tested in 2 sessions (sessions occur approximately one week apart) at ages 18 (chronological), 18 (adjusted; applicable to pre-terms), 24, 30, 36, 42, 48, and 54 months. Each session typically lasts from 30 to 60 minutes, depending on the age of the child and number of breaks taken.
RISKS AND BENEFITS
There are no foreseeable risks or discomforts to you or your child in participating in this research. All the procedures are observational and non-intrusive. The investigators pace each session appropriately and give breaks as needed to enable your child to enjoy and complete the session. Your child will not be pressured to continue in the event that he or she becomes upset, tired, or resistant at any point during the session. If for any reason you or your child does not want to continue, the session will be ended immediately with no penalty.
The investigators cannot and do not guarantee or promise that you will receive any benefits from this study, apart from the payment and the satisfaction of participating in developmental research. If appropriate, the investigators provide information regarding resources that may be helpful in addressing any concerns regarding your child's development.
There are no direct costs to you for participating in this study. Neither you, nor your insurance provider, will be charged for the costs of any of the procedures performed for the purpose of this research study. The National Institute of Health is providing financial support for this study.
PARTICIPANT'S RIGHTS
If you have read this form and have decided to allow your child to participate in this project, please understand your child's participation is voluntary and your child has the right to withdraw his/her consent or discontinue participation at any time without penalty or loss of benefits to which he/she is otherwise entitled. Your child has the right to refuse to answer particular questions. The video record of the session will be identified by a code number, not by name. This record will be accessible only to the project directors and members of the project staff, unless you give your explicit permission for others to view it for scientific or educational purposes. All records will be stored securely so that your child's individual privacy will be maintained. In addition, your child's identity will remain private in all publications resulting from the study. Five years following the completion of your child's participation in this study, the investigators will destroy all raw videotapes.
- Conditions
- Language Development
- Keywords
- preterm, premature, prematurity, children, child, kid, toddler, infant, baby, language, development, skills, listening, talking, communication, speech, processing
- Medical subject headings
- Premature Birth, Deafness, Autosomal Recessive 1A, Language, Speech, Communication
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 | ≥37 weeks gestation; 18 months old at the start of the study | |
| Preterm Children | <33 weeks gestation; 18 months old at the start of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Looking-While-Listening Task
Measured: 18 months, 18 months adjusted, 24 months, 30 months, & 36 months
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 2010
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DevelopmentStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
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 UniversityAnne Fernald, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599780
- Sponsor's protocol ID
- 18354
- Status last verified
- Apr 2018
- First submitted
- 10 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
- On- and Off-line Measures of Language Development in Preterm Children
- ClinicalTrials.gov ID
- NCT01599780
- Acronym / sponsor ID
- 18354
- Conditions
- Language Development
- Keywords
- preterm, premature, prematurity, children, child, kid, toddler, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (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.
This research investigates the ways in which preterm birth affects how very young children learn to speak and understand language, and how older children gain efficiency in language processing. The investigators observe how children at different ages learn new words and comprehend familiar words, how they communicate effectively with others, and how they use both linguistic and non-linguistic skills in problem-solving. All of the activities in the investigators' studies are designed to be age-appropriate and fun for children.
Detailed description
In a typical session, the investigators video-record your child participating in one or more engaging activities with you and/or a member of the staff.
- In one type of task, your child looks at colorful pictures on a video screen while listening to recorded speech referring to the pictures. The investigators may vary factors in the speech stimuli such as word familiarity or sentence structure to learn more about the development of language understanding. Your child is seated on your lap throughout the session. From the video record, the investigators can later look at your child's gaze patterns in response to speech.
- In another type of task, the investigators observe children interacting with a staff member in the playroom. In these game-like activities, your child may be asked to play with toys, name or point to pictures, repeat sequences of words or sentences, tell stories, imitate hand movements, or solve puzzles. These observations help the investigators understand how language development relates to other types of cognitive activities in children at different ages.
- In a third type of task, the investigators observe how children interact spontaneously in a less structured situation. In some cases, the investigators observe you as you play with your child in a playroom. The investigators will provide you with a selection of toys appropriate to your child's age, and ask you to engage with your child as you would at home. From these observations, the investigators learn how children at different ages respond to language in the context of social interaction.
The investigators may also collect a language questionnaire and similar forms containing basic information about your child's development. Additionally, the investigators may review your child's medical records, including ultrasounds and MRI scans, to gain a better understanding of your child's medical history. All information is used for purposes of basic research on language learning only, and will not constitute a clinical assessment or evaluation.
TIME INVOLVEMENT
In this longitudinal study, each child is expected to come for a total of 12-16 sessions of behavioral testing, spread out over 3 years. Children are tested in 2 sessions (sessions occur approximately one week apart) at ages 18 (chronological), 18 (adjusted; applicable to pre-terms), 24, 30, 36, 42, 48, and 54 months. Each session typically lasts from 30 to 60 minutes, depending on the age of the child and number of breaks taken.
RISKS AND BENEFITS
There are no foreseeable risks or discomforts to you or your child in participating in this research. All the procedures are observational and non-intrusive. The investigators pace each session appropriately and give breaks as needed to enable your child to enjoy and complete the session. Your child will not be pressured to continue in the event that he or she becomes upset, tired, or resistant at any point during the session. If for any reason you or your child does not want to continue, the session will be ended immediately with no penalty.
The investigators cannot and do not guarantee or promise that you will receive any benefits from this study, apart from the payment and the satisfaction of participating in developmental research. If appropriate, the investigators provide information regarding resources that may be helpful in addressing any concerns regarding your child's development.
There are no direct costs to you for participating in this study. Neither you, nor your insurance provider, will be charged for the costs of any of the procedures performed for the purpose of this research study. The National Institute of Health is providing financial support for this study.
PARTICIPANT'S RIGHTS
If you have read this form and have decided to allow your child to participate in this project, please understand your child's participation is voluntary and your child has the right to withdraw his/her consent or discontinue participation at any time without penalty or loss of benefits to which he/she is otherwise entitled. Your child has the right to refuse to answer particular questions. The video record of the session will be identified by a code number, not by name. This record will be accessible only to the project directors and members of the project staff, unless you give your explicit permission for others to view it for scientific or educational purposes. All records will be stored securely so that your child's individual privacy will be maintained. In addition, your child's identity will remain private in all publications resulting from the study. Five years following the completion of your child's participation in this study, the investigators will destroy all raw videotapes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-Term Children | – | –≥37 weeks gestation; 18 months old at the start of the study |
| Preterm Children | – | –<33 weeks gestation; 18 months old at the start of the study |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born <33 weeks gestation (preterm)
Key inclusion criteria (3 listed)
- <33 weeks gestation
- <1800 grams at birth
- currently ≤ 18 months
Key exclusion criteria (4 listed)
- an active seizure disorder (afebrile seizure within the last year) and/or anticonvulsant medication use
- central nervous system infections, revisions or other complications of a ventriculoperitoneal shunt for treatment for hydrocephalus, and/or congenital malformations
- history of a sensori-neural hearing loss, defined as 4-tone pure-tone average > 25 decibels
- visual impairments
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
The Looking-While-Listening Task
Time frame: 18 months, 18 months adjusted, 24 months, 30 months, & 36 months
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.
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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
Anne Fernald, 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 Language Development, 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 3 inclusion and 4 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.
What does the primary outcome measure?
The Looking-While-Listening Task (time frame: 18 months, 18 months adjusted, 24 months, 30 months, & 36 months). It is what the study was designed to measure, not a finding.
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.