Clinical trial NCT04708652: Neonatal Cerebral Blood Flow and the Neurobehavioral and Handedness Outcomes in Term and Preterm Adolescents
Official title: Relationship Between Neonatal Cerebral Blood Flow Measures and the Neurobehavioral and Handedness Outcomes in Term and Preterm Adolescents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Children
Keywords: handedness
neonatal cerebral blood flow
neurodevelopment
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 190
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study extends our previous intervention research. The current study will recruit them for a follow up of their neuromotor development, handedness and behavior outcome after entering junior high school at 12-14 years of age. Our previous intervention study enrolled 178 VLBW preterm children and 62 term children who were born or admitted at the National Taiwan University Hospital, the Mackay Memorial Hospital and Taipei City Hospital, Branch for Women and Children in Taipei, Taiwan, during the time period of 2006 to 2008.

Brief 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).

Eligibility criteria: Inclusion Criteria:

Joined our previous study

* preterm group: (1) birth weight \<1,500 g; (2) gestational age \<37 weeks;
* term group: (1) birth weight \>2,500 g; (2) gestation age within 38 and 42 weeks; (3) intrauterine growth status as appropriate for gestational age.

Exclusion Criteria:

* Severe neonatal diseases included major neurologic abnormalities, necrotizing enterocolitis, and severe cardiopulmonary disease and major congenital abnormality.

Primary outcomes:
measure: Movement Assessment Battery for Children- 2nd Edition
timeFrame: at age 12-14
measure: Edinburgh Handedness Inventory
timeFrame: at age 12-14
measure: Child Behavior Check List for Ages 4 to 18 Years
timeFrame: at age 12-14
measure: Neonatal Cranial Doppler Ultrasound
timeFrame: at birth (previous data)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatrics, National Taiwan University Hospital
name: Hung-Chieh Chou, MD; PhD.
role: PRINCIPAL_INVESTIGATOR
References: