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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01163188

Enrollment

520

Registered

2010-07-15

Start date

2010-09-30

Completion date

2014-01-31

Last updated

2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

24 Years to 28 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of life	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

Measure	Time frame	Description
Quality of life	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

Countries

Germany

Outcome results