Social Adjustment and Quality of Life After Very Preterm Birth

NCT01163188 | Completed DMC

• 1 other identifier: 01ER0801
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Birth Weight; Premature Birth

Keywords

very low birthweight/ very preterm children; Bavarian Longitudinal Study (BLS); Quality of life and social adjustment in adulthood

Outcome Measures

Primary Outcomes (1)

• Quality of life

  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

Secondary Outcomes (1)

• Quality of life

  3 years

Study Arms (2)

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

Eligibility Criteria

• Age: 24 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• very low birth weight VLBW (\< 1500g birthweight)and/ or
• very preterm birth VPT (\< 32 weeks of gestation)
• Members of the Bavarian Longitudinal Study

You may not qualify if:

• missing compliance

Sponsors & Collaborators

• University Hospital, Bonn: lead
• University of Warwick: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Bundesverband Bunter Kreis e.V.: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator

Study Sites (1)

Institut für Sozialmedizin in der Pädiatrie Augsburg

Augsburg, Bavaria, 86156, Germany

Location

Related Publications (15)

• 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.

  PMID: 19433987 BACKGROUND

• 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.

  PMID: 19886897 BACKGROUND

• 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.

  PMID: 18762526 BACKGROUND

• 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.

  PMID: 23717694 RESULT

• 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.

  PMID: 23726545 RESULT

• 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.

  PMID: 23455605 RESULT

• 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.

  PMID: 22608065 RESULT

• 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.

  PMID: 22698435 RESULT

• 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.

  PMID: 22624879 RESULT

• 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.

  PMID: 21397413 RESULT

• 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.

  PMID: 21159164 RESULT

• 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.

  PMID: 24951075 RESULT

• 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.

  PMID: 24935776 RESULT

• 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.

  PMID: 24630355 RESULT

• 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.

  PMID: 23910570 RESULT

Related Links

• homepage

Biospecimen

Retention: SAMPLES WITHOUT DNA

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MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Peter Bartmann, Prof.

  University of Bonn, Zentrum für Kinderheilkunde, Abt. Neonatologie

  PRINCIPAL INVESTIGATOR

• Dieter Wolke, Prof.

  University of Warwick

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

DE (1)