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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03072537
Other study ID # CrescNet
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 1998
Est. completion date January 1, 2028

Study information

Verified date November 2023
Source University of Leipzig
Contact Roland W Pfäffle, MD
Email roland.pfaeffle@medizin.uni-leipzig.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

CrescNet is a network of primary care physicians and pediatricians (n=219) and endocrinological treatment centers (n=33), established in Leipzig in 1998, whose aim is to improve the early detection of growth disorders. Secondary to this clinical aim, epidemiological analyses, for example on secular trends of growth data of children, are performed.


Description:

Pediatricians participating in CrescNet provide pseudononymized data on patients' height, weight, and head circumferences to the CrescNet registry. Growth data are evaluated by automatized filter algorithms and by a pediatric endocrinologist. CrescNet does not have access to patients or personal patient data. Each participating pediatrician receives a quarterly screening report with recommendations for the work-up of children with abnormal growth or abnormal development of weight or body mass index. The data registry is used for scientific purposes.The collection of data from healthy children allows the generation of evidence based statements about prevalence rates of growth disorders and also about the rates in disorders of weight development. For this, data are provided completely anonymized without allowing conclusions on personal patient data.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000000
Est. completion date January 1, 2028
Est. primary completion date January 1, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: Population based sample with inclusion of any patient seen by primary care or institutional physician/pediatrician, regardless of the objective for the visit (well child visits, acute visits or special requests) Exclusion Criteria: none

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany CrescNet - University of Leipzig Leipzig Saxony

Sponsors (1)

Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (18)

Alff F, Markert J, Zschaler S, Gausche R, Kiess W, Bluher S. Reasons for (non)participating in a telephone-based intervention program for families with overweight children. PLoS One. 2012;7(4):e34580. doi: 10.1371/journal.pone.0034580. Epub 2012 Apr 3. — View Citation

Beger C, Merker A, Mumm R, Gausche R. Growth prediction of small for gestational age infants within the first weeks after birth. Anthropol Anz. 2018 Jun 11;74(5):377-382. doi: 10.1127/anthranz/2018/0820. Epub 2018 Feb 20. — View Citation

Bluher S, Meigen C, Gausche R, Keller E, Pfaffle R, Sabin M, Werther G, Odeh R, Kiess W. Age-specific stabilization in obesity prevalence in German children: a cross-sectional study from 1999 to 2008. Int J Pediatr Obes. 2011 Jun;6(2-2):e199-206. doi: 10. — View Citation

Heger S, Korner A, Meigen C, Gausche R, Keller A, Keller E, Kiess W. Impact of weight status on the onset and parameters of puberty: analysis of three representative cohorts from central Europe. J Pediatr Endocrinol Metab. 2008 Sep;21(9):865-77. doi: 10.1 — View Citation

Herget S, Markert J, Petroff D, Gausche R, Grimm A, Hilbert A, Kiess W, Bluher S. Psychosocial Well-Being of Adolescents Before and After a 1-Year Telephone-Based Adiposity Prevention Study for Families. J Adolesc Health. 2015 Sep;57(3):351-4. doi: 10.1016/j.jadohealth.2015.05.014. — View Citation

Hoepffner W, Pfaffle R, Gausche R, Meigen C, Keller E. Early detection of growth disorders with the CrescNet system at the Leipzig treatment center. Dtsch Arztebl Int. 2011 Feb;108(8):123-8. doi: 10.3238/arztebl.2011.0123. Epub 2011 Feb 25. — View Citation

Kapellen TM, Gausche R, Dost A, Wiegand S, Flechtner-Mors M, Keller E, Kiess W, Holl RW; DPV-Science-Initiative of the German Competence Network Diabetes and the German Competence Network Obesity (Consortium LARGE). Children and adolescents with type 1 di — View Citation

Keller A, Klossek A, Gausche R, Hoepffner W, Kiess W, Keller E. [Selective primary obesity prevention in children]. Dtsch Med Wochenschr. 2009 Jan;134(1-2):13-8. doi: 10.1055/s-0028-1105883. Epub 2008 Dec 17. German. — View Citation

Keller E, Burmeister J, Gausche R, Keller A, Hermanussen M, Kiess W. [Model program for the early detection and optimal treatment of disorders of growth and physical development using a medical competence netwok]. Z Arztl Fortbild Qualitatssich. 2000 Sep;94(8):695-8. German. — View Citation

Keller E, Gausche R, Meigen C, Keller A, Burmeister J, Kiess W. Auxological computer based network for early detection of disorders of growth and weight attainment. J Pediatr Endocrinol Metab. 2002 Feb;15(2):149-56. doi: 10.1515/jpem.2002.15.2.149. — View Citation

Kess A, Spielau U, Beger C, Gausche R, Vogel M, Lipek T, Korner A, Pfaffle R, Kiess W. Further stabilization and even decrease in the prevalence rates of overweight and obesity in German children and adolescents from 2005 to 2015: a cross-sectional and tr — View Citation

Kiess W, Gausche R, Keller A, Burmeister J, Willgerodt H, Keller E. Computer-guided, population-based screening system for growth disorders (CrescNet) and on-line generation of normative data for growth and development. Horm Res. 2001;56 Suppl 1:59-66. doi: 10.1159/000048137. — View Citation

Korner A, Kratzsch J, Gausche R, Schaab M, Erbs S, Kiess W. New predictors of the metabolic syndrome in children--role of adipocytokines. Pediatr Res. 2007 Jun;61(6):640-5. doi: 10.1203/01.pdr.0000262638.48304.ef. — View Citation

Markert J, Alff F, Zschaler S, Gausche R, Kiess W, Bluher S. Prevention of childhood obesity: recruiting strategies via local paediatricians and study protocol for a telephone-based counselling programme. Obes Res Clin Pract. 2013 Dec;7(6):e476-86. doi: 10.1016/j.orcp.2012.07.008. — View Citation

Meigen C, Keller A, Gausche R, Kromeyer-Hauschild K, Bluher S, Kiess W, Keller E. Secular trends in body mass index in German children and adolescents: a cross-sectional data analysis via CrescNet between 1999 and 2006. Metabolism. 2008 Jul;57(7):934-9. d — View Citation

Miersch A, Vogel M, Gausche R, Siekmeyer W, Pfaffle R, Dittrich K, Kiess W. Blood pressure tracking in children and adolescents. Pediatr Nephrol. 2013 Dec;28(12):2351-9. doi: 10.1007/s00467-013-2596-3. — View Citation

Thiele AG, Gausche R, Lindenberg C, Beger C, Arelin M, Rohde C, Mutze U, Weigel JF, Mohnike K, Baerwald C, Scholz M, Kiess W, Pfaffle R, Beblo S. Growth and Final Height Among Children With Phenylketonuria. Pediatrics. 2017 Nov;140(5):e20170015. doi: 10.1 — View Citation

Wagner IV, Paetzold C, Gausche R, Vogel M, Koerner A, Thiery J, Arsene CG, Henrion A, Guettler B, Keller E, Kiess W, Pfaeffle R, Kratzsch J. Clinical evidence-based cutoff limits for GH stimulation tests in children with a backup of results with reference to mass spectrometry. Eur J Endocrinol. 2014 Sep;171(3):389-97. doi: 10.1530/EJE-14-0165. Epub 2014 Jun 24. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary growth disorders Early detection of growth disorders in childhood and adolescent development. For this, not only absolute data but also growth velocity data are evaluated. 18 years
Primary obesity detection of critical age periods for the development of obesity. For this, not only absolute data but also growth velocity data are evaluated. 18 years
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