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UnknownNCT04708652

Neonatal Cerebral Blood Flow and the Neurobehavioral and Handedness Outcomes in Term and Preterm Adolescents

Relationship Between Neonatal Cerebral Blood Flow Measures and the Neurobehavioral and Handedness Outcomes in Term and Preterm Adolescents

Status
Unknown
Phase
Study type
Observational
Enrollment
190 (estimated)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
12 Years – 14 Years
Healthy volunteers
Accepted

Summary

The results will provide insightful information to understand the process of neural development and the predictive value of early cerebral blood flow measures on longitudinal neurodevelopment and handedness outcomes in preterm and term adolescents. The findings also contribute to the understanding of effectiveness of early intervention on long-term neurodevelopmental outcome in preterm children at adolescence. Our study has three hypotheses as below: 1. The preterm intervention group have higher neuromotor scores, lower behavioral problem scores and higher incidence of right-handedness than the preterm control group. 2. The preterm intervention group have comparable neuromotor scores, behavioral problem scores and incidence of right-handedness than the term adolescents. 3. The neonatal cerebral blood flow velocity asymmetry measures are significantly associated with the infant, preschool, school and adolescent neurodevelopment and handedness outcomes in preterm children with very low birth weight and term children.

Detailed description

The term and preterm children have previously been administered Cranial Doppler Ultrasound and neurobehavioral assessment at term age, and neurodevelopmental assessment in the neonatal period, infancy, preschool and school age (Bayley Scales of Infant and Toddler Development-3rd edition, Movement Assessment Battery for Children-2nd Edition, Child Behavior Check List/4-18, Wechsler Pre-School and Primary Scales of Intelligence-Revised, and Developmental Test of Visual-Motor Integration - 6th Edition). All families will be contacted via phone call and mail to participate in this study. Children and their parents will be examined for child neuromotor development, handedness and behavior when the children reach 12-14 years of age. All measures will be conducted at the Infant Motor Development Laboratory, School of Physical Therapy, National Taiwan University. The outcome measures in this study will consist of the growth (weight and height), neuromotor function (Movement Assessment Battery for Children-2nd Edition), handedness (Edinburgh Handedness Inventory) and behavior (child report and parent report of Child Behavior Check List for Ages 4-18 Years).

Conditions

Interventions

TypeNameDescription
OTHERNo interventionNo intervention

Timeline

Start date
2021-02-01
Primary completion
2021-10-31
Completion
2021-12-31
First posted
2021-01-14
Last updated
2021-01-19

Source: ClinicalTrials.gov record NCT04708652. Inclusion in this directory is not an endorsement.