Social Adjustment and Quality of Life After Very Preterm Birth

NCT ID: NCT01163188

Last Updated: 2014-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low Birth Weight Premature Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Controls

Term born children of the Bavarian Longitudinal Study

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

24 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Warwick

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

Bundesverband Bunter Kreis e.V.

INDUSTRY

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Peter Bartmann

Prof. Dr. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Bartmann, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Bonn, Zentrum für Kinderheilkunde, Abt. Neonatologie

Dieter Wolke, Prof.

Role: STUDY_DIRECTOR

University of Warwick

Locations

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Institut für Sozialmedizin in der Pädiatrie Augsburg

Augsburg, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 19433987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19886897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18762526 (View on PubMed)

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.

Reference Type RESULT
PMID: 23717694 (View on PubMed)

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.

Reference Type RESULT
PMID: 23726545 (View on PubMed)

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.

Reference Type RESULT
PMID: 23455605 (View on PubMed)

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.

Reference Type RESULT
PMID: 22608065 (View on PubMed)

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.

Reference Type RESULT
PMID: 22698435 (View on PubMed)

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.

Reference Type RESULT
PMID: 22624879 (View on PubMed)

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.

Reference Type RESULT
PMID: 21397413 (View on PubMed)

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.

Reference Type RESULT
PMID: 21159164 (View on PubMed)

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.

Reference Type RESULT
PMID: 24951075 (View on PubMed)

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.

Reference Type RESULT
PMID: 24935776 (View on PubMed)

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.

Reference Type RESULT
PMID: 24630355 (View on PubMed)

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.

Reference Type RESULT
PMID: 23910570 (View on PubMed)

Related Links

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Other Identifiers

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01ER0801

Identifier Type: -

Identifier Source: org_study_id

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