Functional and structural brain problems underlying language development disorders in preterm children followed up at age 9

Functional and structural brain problems underlying language development disorders in preterm children followed up at age 9 - Brain problems in preterm children with language development disorders.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46275

Enrollment

134

Registered

2016-01-20

Start date

2016-11-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

language and speech development communication disorder language development disorders

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: For preterm subjects (N37 weeks of gestation) and an individual child must be matched to one of the preterm subjects with in respect to age, gender and education level of the mother.

Exclusion criteria

Exclusion criteria: Participants (preterm-born and term-born) with a permanent (sensorineural) hearing loss from >20 dB at the best ear, measured with pure tone audiometry, will be excluded from participation.;Exclusion criteria for making the MRI scan in the optional additional visit are: (1) Non-removable non-MRI compatible implants; (2) Claustrophobia

Design outcomes

Primary

Measure	Time frame
The main outcome measure is the Core language score measured by the Clinical Evaluation of Language Fundamentals-4 (CELF).	—

Secondary

Measure	Time frame
The secondary outcome measures are: receptive vocabulary (Peabody Picture Vocabulary Test * PPVT); narrative ability (Renfrew Bus-story), functional brain synchronisation (EERG/ERP), academic achievement (Cito-scores), intelligence quotient (Wechsler Intelligence scale for children), complex hearing (DDT), behaviour (Child Behaviour Checklist * CBCL), executive functions (Behaviour Rating Inventory of Executive Function * BRIEF), the competence experience of the child (Competence Experience Scale for Children * CESC), intelligibility (Intelligibility in Context Scale * ICS), parents satisfaction with the childs communication in every-day communication (VAS-scale and Childrens Communication Checklist - CCC-2); receptive vocabulary of one of the parents (Peabody Picture Vocabulary Test PPVT) and quantifiable microstructural connectivity of both brain hemispheres using advanced Magnetic Resonance Imaging (MRI) scan sequences (so called diffusion tensor imaging sequences).	—

Measure

Time frame

The secondary outcome measures are: receptive vocabulary (Peabody Picture Vocabulary Test * PPVT); narrative ability (Renfrew Bus-story), functional brain synchronisation (EERG/ERP), academic achievement (Cito-scores), intelligence quotient (Wechsler Intelligence scale for children), complex hearing (DDT), behaviour (Child Behaviour Checklist * CBCL), executive functions (Behaviour Rating Inventory of Executive Function * BRIEF), the competence experience of the child (Competence Experience Scale for Children * CESC), intelligibility (Intelligibility in Context Scale * ICS), parent*s satisfaction with the child*s communication in every-day communication (VAS-scale and Children*s Communication Checklist - CCC-2); receptive vocabulary of one of the parents (Peabody Picture Vocabulary Test * PPVT) and quantifiable microstructural connectivity of both brain hemispheres using advanced Magnetic Resonance Imaging (MRI) scan sequences (so called diffusion tensor imaging sequences).

—

Countries

Netherlands

Outcome results