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Language DevelopmentNCT01599780

Language Development in Preterm Children

An observational study of Language Development, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Stanford University

    Stanford, California, 94305

Other trials in United States

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.

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 groups in NCT01599780
Study groupRoleWhat 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.

  1. 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.

  1. First posted16 May 2012 (estimated)
  2. Study startJan 2010
  3. Primary completion28 Feb 2018
  4. Study completion28 Feb 2018

Resources

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)
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

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.

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