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

NCT04708652 | Unknown

• 1 other identifier: 202004122RINC
• Study Type: observational
• Target: 190
• Locations: 0 countries
• Sites: N/A

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. 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. 2.The preterm intervention group have comparable neuromotor scores, behavioral problem scores and incidence of right-handedness than the term adolescents.
3. 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.

Conditions

Preterm Children

Keywords

handedness; neonatal cerebral blood flow; neurodevelopment

Outcome Measures

Primary Outcomes (4)

• 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

• Edinburgh Handedness Inventory

  questionnaire, the assessment of the handedness, not scoring system, not relation to good or bad.

  at age 12-14

• 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

• Neonatal Cranial Doppler Ultrasound

  Cerebral blood flow velocity of the bilateral middle cerebral arteries

  at birth (previous data)

Study Arms (2)

preterm children

Our previous intervention study enrolled 178 VLBW (birth body weight less than 1,500 gm) preterm 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. No any intervention was conducted, just the observation.

Other: No intervention

term children

Our previous intervention study enrolled 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. No any intervention was conducted, just the observation.

Other: No intervention

Interventions

No intervention OTHER

No intervention

preterm children; term children

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Officials

• Hung-Chieh Chou, MD; PhD.

  Department of Pediatrics, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Chieh Chou, MD; PhD.

CONTACT

+886-2312-3456; hcchou@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: February 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 19, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share