Social Adjustment and Quality of Life After Very Preterm Birth
8 de agosto de 2014 actualizado por: Peter Bartmann, University Hospital, Bonn
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
All probands have been assessed previously, neonatally and at additional six time points, the last time at the age of 12-13 years.
The focus will be the identification of risk, protective and resiliency factors for cognitive and behavioural development and quality of life.
On the basis of previously assessed data statistical modelling of child development until age 8.5 years will be conducted across the total range of gestation from 26-42 weeks to identify social factors amenable to intervention which could be associated with a positive development especially in moderate prematurity.
In addition, cross-validation of the findings is planned by means of comparisons with three international studies (Millenium Cohort, GB; POPS, NL; EPICure, GB).
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.
In line with the objectives of funding there will be a further follow-up of the BLS to answer important questions regarding health and development of very small preterms.
Tipo de estudio
De observación
Inscripción (Actual)
520
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bavaria
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Augsburg, Bavaria, Alemania, 86156
- Institut für Sozialmedizin in der Pädiatrie Augsburg
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
24 años a 28 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Very low birthweight (< 1500g birthweight) and/ or very preterm children (< 32 weeks of gestation) and a control group of term born children from the Bavarian Longitudinal Study
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Proband
Very low birth weight children (< 32 weeks of gestation) and/ or Very preterm children (< 1500 g birthweight) of the Bavarian Longitudinal Study
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Controls
Term born children of the Bavarian Longitudinal Study
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Quality of life
Periodo de tiempo: 3 years
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Quality of life
Periodo de tiempo: 3 years
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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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Peter Bartmann, Prof., University of Bonn, Zentrum für Kinderheilkunde, Abt. Neonatologie
- Director de estudio: Dieter Wolke, Prof., University of Warwick
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2010
Finalización primaria (Actual)
1 de enero de 2014
Finalización del estudio (Actual)
1 de enero de 2014
Fechas de registro del estudio
Enviado por primera vez
14 de julio de 2010
Primero enviado que cumplió con los criterios de control de calidad
14 de julio de 2010
Publicado por primera vez (Estimar)
15 de julio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de agosto de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
8 de agosto de 2014
Última verificación
1 de agosto de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01ER0801
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