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

Preterm Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04708652
• Other study ID #: 202004122RINC
• Status: Not yet recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: National Taiwan University Hospital
• Contact: Hung-Chieh Chou, MD; PhD.
• Phone: +886-2312-3456
• Email: hcchou[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 190
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Children

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Assessment Battery for Children- 2nd Edition	assess movement, <5th percentile categorized as coordinated impairment; 5th-15th percentile categorized as borderline suspicious coordinated impairment; >15th percentile categorized as normal.	at age 12-14
Primary	Edinburgh Handedness Inventory	questionnaire, the assessment of the handedness, not scoring system, not relation to good or bad.	at age 12-14
Primary	Child Behavior Check List for Ages 4 to 18 Years	questionnaire, the assessment of the child behavior, not scoring system, not relation to good or bad.	at age 12-14
Primary	Neonatal Cranial Doppler Ultrasound	Cerebral blood flow velocity of the bilateral middle cerebral arteries	at birth (previous data)