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Social Adjustment and Quality of Life After Very Preterm Birth

This study has been completed.
Sponsor:
Collaborators:
University of Warwick
Ludwig-Maximilians - University of Munich
ISPA (institue for socialmedizine in paediatrics Augsburg)-Bunter Kreis gGmbH, Augsburg
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
Peter Bartmann, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01163188
First received: July 14, 2010
Last updated: August 8, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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



Biospecimen Retention:   Samples Without DNA

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Enrollment: 520
Study Start Date: September 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163188

Locations
Germany
Institut für Sozialmedizin in der Pädiatrie Augsburg
Augsburg, Bavaria, Germany, 86156
Sponsors and Collaborators
University Hospital, Bonn
University of Warwick
Ludwig-Maximilians - University of Munich
ISPA (institue for socialmedizine in paediatrics Augsburg)-Bunter Kreis gGmbH, Augsburg
Heinrich-Heine University, Duesseldorf
Investigators
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: August 8, 2014
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
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014