- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01163188
Social Adjustment and Quality of Life After Very Preterm Birth
Social Adjustment and Quality of Life After Very Preterm Birth: Risk and Resiliency From Infancy to Adulthood
The major aim is the follow-up of the highest risk group (< 32 weeks gestation/ < 1500 birthweight) and their controls of the Bavarian Longitudinal Study (BLS) at the age of 24-27 years. The focus will be the identification of risk, protective and resiliency factors for cognitive and behavioural development and quality of life.
MRIs of the central nervous system will be conducted to examine aberrant activation patterns during the "attention network task" in stratified subgroups. Data driven MRI methods will be evaluated in relation to clinical, behavioural and developmental parameters.
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Bavaria
-
Augsburg, Bavaria, Alemanha, 86156
- Institut für Sozialmedizin in der Pädiatrie Augsburg
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- very low birth weight VLBW (< 1500g birthweight)and/ or
- very preterm birth VPT (< 32 weeks of gestation)
- Members of the Bavarian Longitudinal Study
Exclusion Criteria:
- missing compliance
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Proband
Very low birth weight children (< 32 weeks of gestation) and/ or Very preterm children (< 1500 g birthweight) of the Bavarian Longitudinal Study
|
|
Controls
Term born children of the Bavarian Longitudinal Study
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of life
Prazo: 3 years
|
Psychologic Interview, face-to-face in Adulthood on one day: Life Course Interview Wechsler Adult Intelligence Scale Diagnostic Expertsystem Interview for psychotic Symptoms Broad Autism Phenotype Questionaire DANVA Questionaire for ADHD Symptoms TRCB Health Utility Index London Handicap Scale WHO-Quality of Life Satisfaction with Life Scale ANT-I Task Additional Lenght, Weight, Head-, Waist-, Hipfcircumferende were measured. These examinations will be matched with these of previous examinations. At the second examinationday the selected probands who are physically and mentally able to undergo a functional MRI, will be examined with: structure-examination DTI Resting Brain ANT N-back These examination will be compared with literature data. |
3 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of life
Prazo: 3 years
|
At the psychological interview the testinstrumentes can be enlarged if possible: Rapid Automatized Naming Test Color -Word Interferencetest Regensburger verbal fluency test Visual Search and Attention Test Smily task Beck Depression Inventar Achenbach Young Adult Self Report Pittsburgh Sleep Quality index Warwick Edinburgh Mental Wellbeing Scale questionaire for generally health Rosenberg Skala self-esteem mass Arnett Inventory of Sensation Seeking Big Five Inventory-10 |
3 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Peter Bartmann, Prof., University of Bonn, Zentrum für Kinderheilkunde, Abt. Neonatologie
- Diretor de estudo: Dieter Wolke, Prof., University of Warwick
Publicações e links úteis
Publicações Gerais
- Wolke D, Schmid G, Schreier A, Meyer R. Crying and feeding problems in infancy and cognitive outcome in preschool children born at risk: a prospective population study. J Dev Behav Pediatr. 2009 Jun;30(3):226-38. doi: 10.1097/DBP.0b013e3181a85973.
- Schmid G, Schreier A, Meyer R, Wolke D. A prospective study on the persistence of infant crying, sleeping and feeding problems and preschool behaviour. Acta Paediatr. 2010 Feb;99(2):286-90. doi: 10.1111/j.1651-2227.2009.01572.x. Epub 2009 Nov 2.
- Verrips E, Vogels T, Saigal S, Wolke D, Meyer R, Hoult L, Verloove-Vanhorick SP. Health-related quality of life for extremely low birth weight adolescents in Canada, Germany, and the Netherlands. Pediatrics. 2008 Sep;122(3):556-61. doi: 10.1542/peds.2007-1043.
- Jaekel J, Baumann N, Wolke D. Effects of gestational age at birth on cognitive performance: a function of cognitive workload demands. PLoS One. 2013 May 24;8(5):e65219. doi: 10.1371/journal.pone.0065219. Print 2013.
- Wolke D, Chernova J, Eryigit-Madzwamuse S, Samara M, Zwierzynska K, Petrou S. Self and parent perspectives on health-related quality of life of adolescents born very preterm. J Pediatr. 2013 Oct;163(4):1020-6.e2. doi: 10.1016/j.jpeds.2013.04.030. Epub 2013 May 30.
- Johnson S, Wolke D. Behavioural outcomes and psychopathology during adolescence. Early Hum Dev. 2013 Apr;89(4):199-207. doi: 10.1016/j.earlhumdev.2013.01.014. Epub 2013 Feb 27.
- Jaekel J, Wolke D, Bartmann P. Poor attention rather than hyperactivity/impulsivity predicts academic achievement in very preterm and full-term adolescents. Psychol Med. 2013 Jan;43(1):183-96. doi: 10.1017/S0033291712001031. Epub 2012 May 21.
- Hall J, Wolke D. A comparison of prematurity and small for gestational age as risk factors for age 6-13 year emotional problems. Early Hum Dev. 2012 Oct;88(10):797-804. doi: 10.1016/j.earlhumdev.2012.05.005. Epub 2012 Jun 12.
- Jaekel J, Wolke D, Chernova J. Mother and child behaviour in very preterm and term dyads at 6 and 8 years. Dev Med Child Neurol. 2012 Aug;54(8):716-23. doi: 10.1111/j.1469-8749.2012.04323.x. Epub 2012 May 24.
- Heinonen K, Raikkonen K, Pesonen AK, Andersson S, Kajantie E, Eriksson JG, Wolke D, Lano A. Longitudinal study of smoking cessation before pregnancy and children's cognitive abilities at 56 months of age. Early Hum Dev. 2011 May;87(5):353-9. doi: 10.1016/j.earlhumdev.2011.02.002. Epub 2011 Mar 11.
- Heinonen K, Raikkonen K, Pesonen AK, Andersson S, Kajantie E, Eriksson JG, Wolke D, Lano A. Behavioural symptoms of attention deficit/hyperactivity disorder in preterm and term children born small and appropriate for gestational age: a longitudinal study. BMC Pediatr. 2010 Dec 15;10:91. doi: 10.1186/1471-2431-10-91.
- Schmid G, Wolke D. Preschool regulatory problems and attention-deficit/hyperactivity and cognitive deficits at school age in children born at risk: different phenotypes of dysregulation? Early Hum Dev. 2014 Aug;90(8):399-405. doi: 10.1016/j.earlhumdev.2014.05.001. Epub 2014 Jun 2.
- Bauml JG, Daamen M, Meng C, Neitzel J, Scheef L, Jaekel J, Busch B, Baumann N, Bartmann P, Wolke D, Boecker H, Wohlschlager AM, Sorg C. Correspondence Between Aberrant Intrinsic Network Connectivity and Gray-Matter Volume in the Ventral Brain of Preterm Born Adults. Cereb Cortex. 2015 Nov;25(11):4135-45. doi: 10.1093/cercor/bhu133. Epub 2014 Jun 16.
- Jaekel J, Wolke D. Preterm birth and dyscalculia. J Pediatr. 2014 Jun;164(6):1327-32. doi: 10.1016/j.jpeds.2014.01.069. Epub 2014 Mar 12.
- Wolke D, Jaekel J, Hall J, Baumann N. Effects of sensitive parenting on the academic resilience of very preterm and very low birth weight adolescents. J Adolesc Health. 2013 Nov;53(5):642-7. doi: 10.1016/j.jadohealth.2013.06.014. Epub 2013 Jul 30.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 01ER0801
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .