NCT01599780

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

8.2 years

First QC Date

May 10, 2012

Last Update Submit

April 16, 2018

Conditions

Keywords

pretermprematureprematuritychildrenchildkidtoddlerinfantbabylanguagedevelopmentskillslisteningtalkingcommunicationspeechprocessing

Outcome Measures

Primary Outcomes (1)

  • The Looking-While-Listening Task

    18 months, 18 months adjusted, 24 months, 30 months, & 36 months

Study Arms (2)

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

Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children born \<33 weeks gestation (preterm)

You may qualify if:

  • \<33 weeks gestation
  • \<1800 grams at birth
  • currently ≤ 18 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Premature BirthDeafness, Autosomal Recessive 1ALanguageSpeechCommunication

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehaviorVerbal Behavior

Study Officials

  • Heidi M Feldman, MD/PhD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Anne Fernald, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 16, 2012

Study Start

January 1, 2010

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations