Clinical Trials Directory

Trials / Completed

CompletedNCT01163188

Social Adjustment and Quality of Life After Very Preterm Birth

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

Status
Completed
Phase
Study type
Observational
Enrollment
520 (actual)
Sponsor
University Hospital, Bonn · Academic / Other
Sex
All
Age
24 Years – 28 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2010-09-01
Primary completion
2014-01-01
Completion
2014-01-01
First posted
2010-07-15
Last updated
2014-08-11

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01163188. Inclusion in this directory is not an endorsement.