Low Birth WeightNCT01163188
Social Adjustment and Quality of Life After Very Preterm Birth
An observational study of Low Birth Weight and Premature Birth, run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 28 years
- Conditions the study is for
- Low Birth Weight, Premature Birth
- How many people
- 520 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 28 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- very low birth weight VLBW (< 1500g birthweight)and/ or
- very preterm birth VPT (< 32 weeks of gestation)
- Members of the Bavarian Longitudinal Study
Who cannot join
- missing compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Sozialmedizin in der Pädiatrie Augsburg
Augsburg, Bavaria, 86156
About this study
Official title: Social Adjustment and Quality of Life After Very Preterm Birth: Risk and Resiliency From Infancy to Adulthood
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.
Read the 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
- Low Birth Weight, Premature Birth
- Keywords
- very low birthweight/ very preterm children, Bavarian Longitudinal Study (BLS), Quality of life and social adjustment in adulthood
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
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.
Measured: 3 years
Secondary outcomes (1)
Quality of life
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick, Ludwig-Maximilians - University of Munich, Bundesverband Bunter Kreis e.V., Heinrich-Heine University, Duesseldorf
- Responsible party
- Principal investigator, Peter Bartmann, University Hospital, Bonn
- Investigators
- Peter Bartmann, Prof., Principal investigator, University of Bonn, Zentrum für Kinderheilkunde, Abt. NeonatologieDieter Wolke, Prof., Study director, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163188
- Sponsor's protocol ID
- 01ER0801
- Status last verified
- Aug 2014
- First submitted
- 14 Jul 2010
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wolke D, Schmid G, Schreier A, Meyer R. Crying and feeding problems in infancy and cognitive outcome in preschool children born at risk: a prospective population study. J Dev Behav Pediatr. 2009 Jun;30(3):226-38. doi: 10.1097/DBP.0b013e3181a85973.
PubMed 19433987Schmid G, Schreier A, Meyer R, Wolke D. A prospective study on the persistence of infant crying, sleeping and feeding problems and preschool behaviour. Acta Paediatr. 2010 Feb;99(2):286-90. doi: 10.1111/j.1651-2227.2009.01572.x. Epub 2009 Nov 2.
PubMed 19886897Verrips E, Vogels T, Saigal S, Wolke D, Meyer R, Hoult L, Verloove-Vanhorick SP. Health-related quality of life for extremely low birth weight adolescents in Canada, Germany, and the Netherlands. Pediatrics. 2008 Sep;122(3):556-61. doi: 10.1542/peds.2007-1043.
PubMed 18762526Jaekel J, Baumann N, Wolke D. Effects of gestational age at birth on cognitive performance: a function of cognitive workload demands. PLoS One. 2013 May 24;8(5):e65219. doi: 10.1371/journal.pone.0065219. Print 2013.
PubMed 23717694Wolke D, Chernova J, Eryigit-Madzwamuse S, Samara M, Zwierzynska K, Petrou S. Self and parent perspectives on health-related quality of life of adolescents born very preterm. J Pediatr. 2013 Oct;163(4):1020-6.e2. doi: 10.1016/j.jpeds.2013.04.030. Epub 2013 May 30.
PubMed 23726545Johnson S, Wolke D. Behavioural outcomes and psychopathology during adolescence. Early Hum Dev. 2013 Apr;89(4):199-207. doi: 10.1016/j.earlhumdev.2013.01.014. Epub 2013 Feb 27.
PubMed 23455605Jaekel J, Wolke D, Bartmann P. Poor attention rather than hyperactivity/impulsivity predicts academic achievement in very preterm and full-term adolescents. Psychol Med. 2013 Jan;43(1):183-96. doi: 10.1017/S0033291712001031. Epub 2012 May 21.
PubMed 22608065Hall J, Wolke D. A comparison of prematurity and small for gestational age as risk factors for age 6-13 year emotional problems. Early Hum Dev. 2012 Oct;88(10):797-804. doi: 10.1016/j.earlhumdev.2012.05.005. Epub 2012 Jun 12.
PubMed 22698435Jaekel J, Wolke D, Chernova J. Mother and child behaviour in very preterm and term dyads at 6 and 8 years. Dev Med Child Neurol. 2012 Aug;54(8):716-23. doi: 10.1111/j.1469-8749.2012.04323.x. Epub 2012 May 24.
PubMed 22624879Heinonen K, Raikkonen K, Pesonen AK, Andersson S, Kajantie E, Eriksson JG, Wolke D, Lano A. Longitudinal study of smoking cessation before pregnancy and children's cognitive abilities at 56 months of age. Early Hum Dev. 2011 May;87(5):353-9. doi: 10.1016/j.earlhumdev.2011.02.002. Epub 2011 Mar 11.
PubMed 21397413Heinonen K, Raikkonen K, Pesonen AK, Andersson S, Kajantie E, Eriksson JG, Wolke D, Lano A. Behavioural symptoms of attention deficit/hyperactivity disorder in preterm and term children born small and appropriate for gestational age: a longitudinal study. BMC Pediatr. 2010 Dec 15;10:91. doi: 10.1186/1471-2431-10-91.
PubMed 21159164Schmid G, Wolke D. Preschool regulatory problems and attention-deficit/hyperactivity and cognitive deficits at school age in children born at risk: different phenotypes of dysregulation? Early Hum Dev. 2014 Aug;90(8):399-405. doi: 10.1016/j.earlhumdev.2014.05.001. Epub 2014 Jun 2.
PubMed 24951075Bauml JG, Daamen M, Meng C, Neitzel J, Scheef L, Jaekel J, Busch B, Baumann N, Bartmann P, Wolke D, Boecker H, Wohlschlager AM, Sorg C. Correspondence Between Aberrant Intrinsic Network Connectivity and Gray-Matter Volume in the Ventral Brain of Preterm Born Adults. Cereb Cortex. 2015 Nov;25(11):4135-45. doi: 10.1093/cercor/bhu133. Epub 2014 Jun 16.
PubMed 24935776Jaekel J, Wolke D. Preterm birth and dyscalculia. J Pediatr. 2014 Jun;164(6):1327-32. doi: 10.1016/j.jpeds.2014.01.069. Epub 2014 Mar 12.
PubMed 24630355Wolke D, Jaekel J, Hall J, Baumann N. Effects of sensitive parenting on the academic resilience of very preterm and very low birth weight adolescents. J Adolesc Health. 2013 Nov;53(5):642-7. doi: 10.1016/j.jadohealth.2013.06.014. Epub 2013 Jul 30.
PubMed 23910570
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Adjustment and Quality of Life After Very Preterm Birth: Risk and Resiliency From Infancy to Adulthood
- ClinicalTrials.gov ID
- NCT01163188
- Acronym / sponsor ID
- 01ER0801
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- University of Warwick, Ludwig-Maximilians - University of Munich, Bundesverband Bunter Kreis e.V., Heinrich-Heine University, Duesseldorf
- Study start
- Sep 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 24 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- very low birth weight VLBW (< 1500g birthweight)and/ or
- very preterm birth VPT (< 32 weeks of gestation)
- Members of the Bavarian Longitudinal Study
Key exclusion criteria (1 listed)
- missing compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Quality of life
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- Background: PubMed 19433987Wolke D, Schmid G, Schreier A, Meyer R. Crying and feeding problems in infancy and cognitive outcome in preschool children born at risk: a prospective population study. J Dev Behav Pediatr. 2009 Jun;30(3):226-38. doi: 10.1097/DBP.0b013e3181a85973.
- Background: PubMed 19886897Schmid G, Schreier A, Meyer R, Wolke D. A prospective study on the persistence of infant crying, sleeping and feeding problems and preschool behaviour. Acta Paediatr. 2010 Feb;99(2):286-90. doi: 10.1111/j.1651-2227.2009.01572.x. Epub 2009 Nov 2.
- Background: PubMed 18762526Verrips E, Vogels T, Saigal S, Wolke D, Meyer R, Hoult L, Verloove-Vanhorick SP. Health-related quality of life for extremely low birth weight adolescents in Canada, Germany, and the Netherlands. Pediatrics. 2008 Sep;122(3):556-61. doi: 10.1542/peds.2007-1043.
- Results publication: PubMed 23717694Jaekel J, Baumann N, Wolke D. Effects of gestational age at birth on cognitive performance: a function of cognitive workload demands. PLoS One. 2013 May 24;8(5):e65219. doi: 10.1371/journal.pone.0065219. Print 2013.
- Results publication: PubMed 23726545Wolke D, Chernova J, Eryigit-Madzwamuse S, Samara M, Zwierzynska K, Petrou S. Self and parent perspectives on health-related quality of life of adolescents born very preterm. J Pediatr. 2013 Oct;163(4):1020-6.e2. doi: 10.1016/j.jpeds.2013.04.030. Epub 2013 May 30.
- Results publication: PubMed 23455605Johnson S, Wolke D. Behavioural outcomes and psychopathology during adolescence. Early Hum Dev. 2013 Apr;89(4):199-207. doi: 10.1016/j.earlhumdev.2013.01.014. Epub 2013 Feb 27.
- Results publication: PubMed 22608065Jaekel J, Wolke D, Bartmann P. Poor attention rather than hyperactivity/impulsivity predicts academic achievement in very preterm and full-term adolescents. Psychol Med. 2013 Jan;43(1):183-96. doi: 10.1017/S0033291712001031. Epub 2012 May 21.
- Results publication: PubMed 22698435Hall J, Wolke D. A comparison of prematurity and small for gestational age as risk factors for age 6-13 year emotional problems. Early Hum Dev. 2012 Oct;88(10):797-804. doi: 10.1016/j.earlhumdev.2012.05.005. Epub 2012 Jun 12.
- Results publication: PubMed 22624879Jaekel J, Wolke D, Chernova J. Mother and child behaviour in very preterm and term dyads at 6 and 8 years. Dev Med Child Neurol. 2012 Aug;54(8):716-23. doi: 10.1111/j.1469-8749.2012.04323.x. Epub 2012 May 24.
- Results publication: PubMed 21397413Heinonen K, Raikkonen K, Pesonen AK, Andersson S, Kajantie E, Eriksson JG, Wolke D, Lano A. Longitudinal study of smoking cessation before pregnancy and children's cognitive abilities at 56 months of age. Early Hum Dev. 2011 May;87(5):353-9. doi: 10.1016/j.earlhumdev.2011.02.002. Epub 2011 Mar 11.
- Results publication: PubMed 21159164Heinonen K, Raikkonen K, Pesonen AK, Andersson S, Kajantie E, Eriksson JG, Wolke D, Lano A. Behavioural symptoms of attention deficit/hyperactivity disorder in preterm and term children born small and appropriate for gestational age: a longitudinal study. BMC Pediatr. 2010 Dec 15;10:91. doi: 10.1186/1471-2431-10-91.
- Results publication: PubMed 24951075Schmid G, Wolke D. Preschool regulatory problems and attention-deficit/hyperactivity and cognitive deficits at school age in children born at risk: different phenotypes of dysregulation? Early Hum Dev. 2014 Aug;90(8):399-405. doi: 10.1016/j.earlhumdev.2014.05.001. Epub 2014 Jun 2.
- homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bartmann, Prof. principal investigator
University of Bonn, Zentrum für Kinderheilkunde, Abt. Neonatologie
Dieter Wolke, Prof. study director
University of Warwick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Birth Weight and Premature Birth, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01163188, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.