Social Adjustment and Quality of Life After Very Preterm Birth
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Purpose
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.
| Condition |
|---|
|
Low Birth Weight Premature Birth |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Social Adjustment and Quality of Life After Very Preterm Birth: Risk and Resiliency From Infancy to Adulthood |
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| Estimated Enrollment: | 600 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Proband
Very low birth weight children (< 32 weeks of gestation) and/ or Very preterm children (< 1500 g birthweight) of the Bavarian Longitudinal Study
|
|
Controls
Term born children of the Bavarian Longitudinal Study
|
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.
Eligibility| Ages Eligible for Study: | 24 Years to 28 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Very low birthweight (< 1500g birthweight) and/ or very preterm children (< 32 weeks of gestation) and a control group of term born children from the Bavarian Longitudinal Study
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
Contacts and Locations| Germany | |
| Institut für Sozialmedizin in der Pädiatrie Augsburg | |
| Augsburg, Bavaria, Germany, 86156 | |
| Principal Investigator: | Peter Bartmann, Prof. | University of Bonn, Zentrum für Kinderheilkunde, Abt. Neonatologie |
| Study Director: | Dieter Wolke, Prof. | University of Warwick |
More Information
Additional Information:
Publications:
| Responsible Party: | Peter Bartmann, Prof. Dr. Dr., University Hospital, Bonn |
| ClinicalTrials.gov Identifier: | NCT01163188 History of Changes |
| Other Study ID Numbers: | 01ER0801 |
| Study First Received: | July 14, 2010 |
| Last Updated: | February 22, 2012 |
| Health Authority: | Germany: Federal Ministry of Education and Research |
Keywords provided by University Hospital, Bonn:
|
very low birthweight/ very preterm children Bavarian Longitudinal Study (BLS) Quality of life and social adjustment in adulthood |
Additional relevant MeSH terms:
|
Birth Weight Premature Birth Body Weight Signs and Symptoms |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on May 16, 2013