The Early Life Clinical Feature and Risk Factors Analysis in Children With Neurodevelopmental Disorders

NCT ID: NCT05430256

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2024-01-01

Brief Summary

The study will be a 5-year retrospective and prospective case control study, included 650 participants, and participants will be divided into four groups.By this research the investigators will achieve several aims:(1) Through the cross-sectional analysis of this study, the investigators can understand the current prevalence of developmental disorders in Taiwan ,especially ADHD and ASD, and the ratio of male to female in school-age children. (2) Analysis of risk factors in preterm infants during pregnancy and infant, and construct the diagnostic predictive models. (3) By the cohort study of premature infants, to analyze early risk factors of premature children with neurological developmental disorders (such as ADHD), and develop the diagnostic predictive models and early interventional tools. (4) Using artificial intelligence and machine learning analysis to analyze the characteristics of preterm and development of diagnostic prediction model of premature infant or premature children combined ADHD. (5) The application of noninvasive physiological signal capture real-time analysis system in screening and evaluation of "premature infant and neurodevelopmental disorders".

Detailed Description

In recent years the issue of low birth rates become more and more serious in many countries. In 2017, the average birth rate is 1.17 for every child-bearing woman in Taiwan, ranking the last among Asian countries. As the declining birth rates, the population of Taiwan will decrease year by year while showing an aging society. It will be an important crisis in Taiwan's future development. Although the declining birth rates in Taiwan year by year, the incidence of premature has not decrease. Moreover, the morbidity and long-term prognosis of preterm infants, will be a significant burden of children, families, and national economy. Therefore, it should be a serious issue of government. According to the above reasons, to keep the "safe pregnancy and normal development of the fetus," "smooth delivery" and even "postpartum newborn healthy growth" and so on, will be very important issues in the future.

Due to advances in medical technology and the improvement of newborn care, makes the very low birth weight preterm infant survival rate greatly improved. However, the improvement of survival rate did not improve the incidence of postnatal morbidity of the preterm infants, and the risk of many neurodevelopmental disorders greatly increased. Many studies have confirmed the long-term prognosis of preterm infants with low birth weight, whom with serious abnormalities in neurocognitive development, language development, motor development and so on. Attention deficit hyperactivity disorder (ADHD) and Autism spectrum disorder (ASD) are common neurodevelopmental disorders. These deficiencies such as inattention, decreased learning ability, behavioral problems and social skills disturbance ....make the children have poor outcome. It is affect children academic achievement and adaptation so great in the future. Therefore, the government, experts and scholars should concern about the issue of the premature and these pediatric neurological development delay and poor prognosis.

Meanwhile, this study will design a 5-year retrospective and prospective case control study, will include 650 participant. And participants will be divided into four groups:(a) Premature children with neurological developmental disorder (such as ADHD): n = 200; (b) Premature children with neurological developmental disorder (such as ASD): n = 50; (c) Premature infants with no neurodevelopmental disorders: n = 200; (d) Age and gender match in non-preterm children: n = 200.

By this research to achieve the aims: (1) Through the cross-sectional analysis of this study, the investigators can understand the current prevalence of developmental disorders in Taiwan ,especially ADHD and ASD, and the ratio of male to female in school-age children. (2) Analysis of risk factors in preterm infants during pregnancy and infant, and construct the diagnostic predictive models. (3) By the cohort study of premature infants, to analyze early risk factors of premature children with neurological developmental disorders (such as ADHD), and develop the diagnostic predictive models and early interventional tools. (4) Using artificial intelligence and machine learning analysis to analyze the characteristics of preterm and development of diagnostic prediction model of premature infant or premature children combined ADHD. (5) The application of noninvasive physiological signal capture real-time analysis system in screening and evaluation of "premature infant and neurodevelopmental disorders".

Conditions

Premature Infant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Premature children with neurological developmental disorder(such as ADHD)

Premature children with neurological developmental disorder (such as ADHD): n = 200

No interventions assigned to this group

Premature children with neurological developmental disorder(such as ASD)

Premature children with neurological developmental disorder (such as ASD): n = 50

No interventions assigned to this group

Premature infants with no neurodevelopmental disorders

Premature infants with no neurodevelopmental disorders: n = 200

No interventions assigned to this group

Age and gender match in non-preterm children

Age and gender match in non-preterm children: n = 200

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. The investigators will collect newborns who born in Chang Gung after 2010 .

2. The investigators will collect 450 premature infants under 37 weeks and 200 non-preterm infants.

3. Participated in the former Ministry of Science and Technology research project ''NSC 101-2314-B-182A-072-MY3'' and project ''106-2314-B-182A-040-MY3'' will be invited to join this study.

4. Parents are willing to sign the subject's consent form.

Exclusion Criteria

1. If children have serious neurological diseases, serious heart problems or serious mental retardation, they will not be able to participate in this study.

2. If parents cannot sign the consent form of the subjects.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Shu Huang, PhD

Role: STUDY_DIRECTOR

Principal Investigator

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Shu Huang, PhD

Role: CONTACT

yushuhuang1212@gmail.com

+886 3 3281200 ext. 3836

Facility Contacts

Yu-Shu Huanh, PhD

Role: primary

yushuhuang1212@gmail.com

+886 3 328200 ext. 3836

References

Accornero VH, Amado AJ, Morrow CE, Xue L, Anthony JC, Bandstra ES. Impact of prenatal cocaine exposure on attention and response inhibition as assessed by continuous performance tests. J Dev Behav Pediatr. 2007 Jun;28(3):195-205. doi: 10.1097/01.DBP.0000268560.72580.f9.

Reference Type: RESULT

PMID: 17565286 (View on PubMed)

Adde L, Helbostad JL, Jensenius AR, Taraldsen G, Grunewaldt KH, Stoen R. Early prediction of cerebral palsy by computer-based video analysis of general movements: a feasibility study. Dev Med Child Neurol. 2010 Aug;52(8):773-8. doi: 10.1111/j.1469-8749.2010.03629.x. Epub 2010 Feb 24.

Reference Type: RESULT

PMID: 20187882 (View on PubMed)

Batton DG, DeWitte DB, Pryce CJ. One hundred consecutive infants born at 23 weeks and resuscitated. Am J Perinatol. 2011 Apr;28(4):299-304. doi: 10.1055/s-0030-1268714. Epub 2010 Nov 29.

Reference Type: RESULT

PMID: 21117014 (View on PubMed)

Biederman J, Monuteaux MC, Mick E, Spencer T, Wilens TE, Silva JM, Snyder LE, Faraone SV. Young adult outcome of attention deficit hyperactivity disorder: a controlled 10-year follow-up study. Psychol Med. 2006 Feb;36(2):167-79. doi: 10.1017/S0033291705006410.

Reference Type: RESULT

PMID: 16420713 (View on PubMed)

Brisson J, Martel K, Serres J, Sirois S, Adrien JL. Acoustic analysis of oral productions of infants later diagnosed with autism and their mother. Infant Ment Health J. 2014 May-Jun;35(3):285-95. doi: 10.1002/imhj.21442. Epub 2014 Mar 31.

Reference Type: RESULT

PMID: 25798482 (View on PubMed)

Bohm HV, Stewart MG, Healy AM. On the Autistic Spectrum Disorder concordance rates of twins and non-twin siblings. Med Hypotheses. 2013 Nov;81(5):789-91. doi: 10.1016/j.mehy.2013.08.019. Epub 2013 Aug 29.

Reference Type: RESULT

PMID: 24055096 (View on PubMed)

Canela C, Buadze A, Dube A, Eich D, Liebrenz M. Skills and compensation strategies in adult ADHD - A qualitative study. PLoS One. 2017 Sep 27;12(9):e0184964. doi: 10.1371/journal.pone.0184964. eCollection 2017.

Reference Type: RESULT

PMID: 28953946 (View on PubMed)

Chu SM, Tsai MH, Hwang FM, Hsu JF, Huang HR, Huang YS. The relationship between attention deficit hyperactivity disorder and premature infants in Taiwanese: a case control study. BMC Psychiatry. 2012 Jul 23;12:85. doi: 10.1186/1471-244X-12-85.

Reference Type: RESULT

PMID: 22824325 (View on PubMed)

Colvert E, Tick B, McEwen F, Stewart C, Curran SR, Woodhouse E, Gillan N, Hallett V, Lietz S, Garnett T, Ronald A, Plomin R, Rijsdijk F, Happe F, Bolton P. Heritability of Autism Spectrum Disorder in a UK Population-Based Twin Sample. JAMA Psychiatry. 2015 May;72(5):415-23. doi: 10.1001/jamapsychiatry.2014.3028.

Reference Type: RESULT

PMID: 25738232 (View on PubMed)

DiMaio S, Grizenko N, Joober R. Dopamine genes and attention-deficit hyperactivity disorder: a review. J Psychiatry Neurosci. 2003 Jan;28(1):27-38.

Reference Type: RESULT

PMID: 12587848 (View on PubMed)

DeVilbiss EA, Gardner RM, Newschaffer CJ, Lee BK. Maternal folate status as a risk factor for autism spectrum disorders: a review of existing evidence. Br J Nutr. 2015 Sep 14;114(5):663-72. doi: 10.1017/S0007114515002470. Epub 2015 Aug 5.

Reference Type: RESULT

PMID: 26243379 (View on PubMed)

Faustman EM, Silbernagel SM, Fenske RA, Burbacher TM, Ponce RA. Mechanisms underlying Children's susceptibility to environmental toxicants. Environ Health Perspect. 2000 Mar;108 Suppl 1(Suppl 1):13-21. doi: 10.1289/ehp.00108s113.

Reference Type: RESULT

PMID: 10698720 (View on PubMed)

Fischl B, Dale AM. Measuring the thickness of the human cerebral cortex from magnetic resonance images. Proc Natl Acad Sci U S A. 2000 Sep 26;97(20):11050-5. doi: 10.1073/pnas.200033797.

Reference Type: RESULT

PMID: 10984517 (View on PubMed)

Ghiassian S, Greiner R, Jin P, Brown MR. Using Functional or Structural Magnetic Resonance Images and Personal Characteristic Data to Identify ADHD and Autism. PLoS One. 2016 Dec 28;11(12):e0166934. doi: 10.1371/journal.pone.0166934. eCollection 2016.

Reference Type: RESULT

PMID: 28030565 (View on PubMed)

Hallmayer J, Cleveland S, Torres A, Phillips J, Cohen B, Torigoe T, Miller J, Fedele A, Collins J, Smith K, Lotspeich L, Croen LA, Ozonoff S, Lajonchere C, Grether JK, Risch N. Genetic heritability and shared environmental factors among twin pairs with autism. Arch Gen Psychiatry. 2011 Nov;68(11):1095-102. doi: 10.1001/archgenpsychiatry.2011.76. Epub 2011 Jul 4.

Reference Type: RESULT

PMID: 21727249 (View on PubMed)

Iannaccone R, Hauser TU, Ball J, Brandeis D, Walitza S, Brem S. Classifying adolescent attention-deficit/hyperactivity disorder (ADHD) based on functional and structural imaging. Eur Child Adolesc Psychiatry. 2015 Oct;24(10):1279-89. doi: 10.1007/s00787-015-0678-4. Epub 2015 Jan 23.

Reference Type: RESULT

PMID: 25613588 (View on PubMed)

Kato I, Groswasser J, Franco P, Scaillet S, Kelmanson I, Togari H, Kahn A. Developmental characteristics of apnea in infants who succumb to sudden infant death syndrome. Am J Respir Crit Care Med. 2001 Oct 15;164(8 Pt 1):1464-9. doi: 10.1164/ajrccm.164.8.2009001.

Reference Type: RESULT

PMID: 11704597 (View on PubMed)

Mazaheri A, Fassbender C, Coffey-Corina S, Hartanto TA, Schweitzer JB, Mangun GR. Differential oscillatory electroencephalogram between attention-deficit/hyperactivity disorder subtypes and typically developing adolescents. Biol Psychiatry. 2014 Sep 1;76(5):422-9. doi: 10.1016/j.biopsych.2013.08.023. Epub 2013 Oct 8.

Reference Type: RESULT

PMID: 24120092 (View on PubMed)

Larroque B, Ancel PY, Marret S, Marchand L, Andre M, Arnaud C, Pierrat V, Roze JC, Messer J, Thiriez G, Burguet A, Picaud JC, Breart G, Kaminski M; EPIPAGE Study group. Neurodevelopmental disabilities and special care of 5-year-old children born before 33 weeks of gestation (the EPIPAGE study): a longitudinal cohort study. Lancet. 2008 Mar 8;371(9615):813-20. doi: 10.1016/S0140-6736(08)60380-3.

Reference Type: RESULT

PMID: 18328928 (View on PubMed)

Other Identifiers

201801537A3

Identifier Type: -

Identifier Source: org_study_id