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Clinical Trials/NCT01163188
NCT01163188
Completed
Not Applicable

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

University Hospital, Bonn1 site in 1 country520 target enrollmentSeptember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Birth Weight
Sponsor
University Hospital, Bonn
Enrollment
520
Locations
1
Primary Endpoint
Quality of life
Status
Completed
Last Updated
11 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
January 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bonn
Responsible Party
Principal Investigator
Principal Investigator

Peter Bartmann

Prof. Dr. Dr.

University Hospital, Bonn

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Quality of life(3 years)

Study Sites (1)

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