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Social Adjustment and Quality of Life After Very Preterm Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01163188
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : August 11, 2014
Sponsor:
Collaborators:
University of Warwick
Ludwig-Maximilians - University of Munich
Bundesverband Bunter Kreis e.V.
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
Peter Bartmann, University Hospital, Bonn

Tracking Information
First Submitted Date July 14, 2010
First Posted Date July 15, 2010
Last Update Posted Date August 11, 2014
Study Start Date September 2010
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2014)		 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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: January 23, 2014)		 Quality of life [ Time Frame: 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Social Adjustment and Quality of Life After Very Preterm Birth
Official Title Social Adjustment and Quality of Life After Very Preterm Birth: Risk and Resiliency From Infancy to 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
hair
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
Condition
  • Low Birth Weight
  • Premature Birth
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 23, 2014)		 520
Original Estimated Enrollment
 (submitted: July 14, 2010)		 600
Actual Study Completion Date January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 24 Years to 28 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01163188
Other Study ID Numbers 01ER0801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Peter Bartmann, University Hospital, Bonn
Original Responsible Party Prof. Dr. Dr. Peter Bartmann, University of Bonn, Neonatology
Current Study Sponsor University Hospital, Bonn
Original Study Sponsor Same as current
Collaborators
  • University of Warwick
  • Ludwig-Maximilians - University of Munich
  • Bundesverband Bunter Kreis e.V.
  • 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
PRS Account University Hospital, Bonn
Verification Date August 2014