Preterm ChildrenNCT04708652
Neonatal Cerebral Blood Flow and the Neurobehavioral and Handedness Outcomes in Term and Preterm Adolescents
An observational study of Preterm Children, run by National Taiwan University Hospital.
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. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Children
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Severe neonatal diseases included major neurologic abnormalities, necrotizing enterocolitis, and severe cardiopulmonary disease and major congenital abnormality.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Relationship Between Neonatal Cerebral Blood Flow Measures and the Neurobehavioral and Handedness Outcomes in Term and Preterm Adolescents
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:
- The preterm intervention group have higher neuromotor scores, lower behavioral problem scores and higher incidence of right-handedness than the preterm control group.
- The preterm intervention group have comparable neuromotor scores, behavioral problem scores and incidence of right-handedness than the term adolescents.
- 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.
Read the 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
- Preterm Children
- Being tested
- No intervention
- Keywords
- handedness, neonatal cerebral blood flow, neurodevelopment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at age 12-14
Edinburgh Handedness Inventory
questionnaire, the assessment of the handedness, not scoring system, not relation to good or bad.
Measured: 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.
Measured: at age 12-14
Neonatal Cranial Doppler Ultrasound
Cerebral blood flow velocity of the bilateral middle cerebral arteries
Measured: at birth (previous data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm ChildrenStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Chieh Chou, MD; PhD., Principal investigator, Department of Pediatrics, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708652
- Sponsor's protocol ID
- 202004122RINC
- Status last verified
- Dec 2020
- First submitted
- 12 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Neonatal Cerebral Blood Flow Measures and the Neurobehavioral and Handedness Outcomes in Term and Preterm Adolescents
- ClinicalTrials.gov ID
- NCT04708652
- Acronym / sponsor ID
- 202004122RINC
- Conditions
- Preterm Children
- Keywords
- handedness, neonatal cerebral blood flow, neurodevelopment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The preterm intervention group have higher neuromotor scores, lower behavioral problem scores and higher incidence of right-handedness than the preterm control group.
- The preterm intervention group have comparable neuromotor scores, behavioral problem scores and incidence of right-handedness than the term adolescents.
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm children | – | Other: No interventionOur 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. |
| term children | – | Other: No interventionOur 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. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe neonatal diseases included major neurologic abnormalities, necrotizing enterocolitis, and severe cardiopulmonary disease and major congenital abnormality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | preterm children, term children |
Primary outcome
Movement Assessment Battery for Children- 2nd Edition
Time frame: at age 12-14
assess movement, <5th percentile categorized as coordinated impairment; 5th-15th percentile categorized as borderline suspicious coordinated impairment; >15th percentile categorized as normal.
Edinburgh Handedness Inventory
Time frame: at age 12-14
questionnaire, the assessment of the handedness, not scoring system, not relation to good or bad.
Child Behavior Check List for Ages 4 to 18 Years
Time frame: at age 12-14
questionnaire, the assessment of the child behavior, not scoring system, not relation to good or bad.
Neonatal Cranial Doppler Ultrasound
Time frame: at birth (previous data)
Cerebral blood flow velocity of the bilateral middle cerebral arteries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Preterm Children
RecruitingObservational study
Assessing Intellectual and Motor Outcomes in High-risk Infants
Cerebral Palsy, Cerebral Palsy (CP)
Recruiting
Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".
Preterm Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Chieh Chou, MD; PhD. principal investigator
Department of Pediatrics, National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Children, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Chieh Chou, MD; PhD. (+886-2312-3456 ext. 71016, hcchou@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Assessment Battery for Children- 2nd Edition (time frame: at age 12-14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.