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Completed

NCT Number: NCT01163188

Social Adjustment and Quality of Life After Very Preterm Birth

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.

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Key information

Conditions

Low Birth Weight Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 year–28 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut für Sozialmedizin in der Pädiatrie Augsburg

Augsburg, Bavaria, 86156, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quality of life

    Time frame: 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.

Secondary outcomes

  1. Quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Collaborators

  • Bundesverband Bunter Kreis e.V.
  • Heinrich-Heine University, Duesseldorf
  • Ludwig-Maximilians - University of Munich
  • University of Warwick

Registry information

Official study title

Social Adjustment and Quality of Life After Very Preterm Birth: Risk and Resiliency From Infancy to Adulthood

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2010
Registry last updated
Aug 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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