Cardiovascular Abnormalities Clinical Trial
— CardioSGAOfficial title:
Cardiovascular Screening in 2-year Old Infants Born Small for Gestational Age Compared With Infants Born Adequate for Gestational Age
NCT number | NCT03758092 |
Other study ID # | CE 106/18 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | July 1, 2018 |
Verified date | November 2018 |
Source | Azienda Ospedaliero Universitaria Maggiore della Carita |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Aims of this study were 1) to evaluate early CV abnormalities in infants born small for gestational age (SGA) at 24 months of age compared with age and sex-matched subjects that were born adequate for gestational age (AGA) 2) to investigate the effect of catch-up growth and the role of breastfeeding on CV risk.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Months to 24 Months |
Eligibility |
Inclusion Criteria: - infants, 24-month old, born at term SGA or AGA Exclusion Criteria: - heart, respiratory, liver and kidney diseases, congenital malformations, genetic diseases, neonatal asphyxia, parenteral nutrition, congenital inborn errors of metabolism, and preterm and twin birth. |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica | Novara |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero Universitaria Maggiore della Carita |
Italy,
Barker DJ, Osmond C, Golding J, Kuh D, Wadsworth ME. Growth in utero, blood pressure in childhood and adult life, and mortality from cardiovascular disease. BMJ. 1989 Mar 4;298(6673):564-7. — View Citation
Crispi F, Bijnens B, Figueras F, Bartrons J, Eixarch E, Le Noble F, Ahmed A, Gratacós E. Fetal growth restriction results in remodeled and less efficient hearts in children. Circulation. 2010 Jun 8;121(22):2427-36. doi: 10.1161/CIRCULATIONAHA.110.937995. Epub 2010 May 24. — View Citation
Dratva J, Breton CV, Hodis HN, Mack WJ, Salam MT, Zemp E, Gilliland F, Kuenzli N, Avol E. Birth weight and carotid artery intima-media thickness. J Pediatr. 2013 May;162(5):906-11.e1-2. doi: 10.1016/j.jpeds.2012.10.060. Epub 2012 Dec 20. — View Citation
Faienza MF, Brunetti G, Delvecchio M, Zito A, De Palma F, Cortese F, Nitti A, Massari E, Gesualdo M, Ricci G, Carbonara S, Giordano P, Cavallo L, Scicchitano P, Ciccone MM. Vascular Function and Myocardial Performance Indices in Children Born Small for Gestational Age. Circ J. 2016;80(4):958-63. doi: 10.1253/circj.CJ-15-1038. Epub 2016 Feb 10. — View Citation
Iruretagoyena JI, Gonzalez-Tendero A, Garcia-Canadilla P, Amat-Roldan I, Torre I, Nadal A, Crispi F, Gratacos E. Cardiac dysfunction is associated with altered sarcomere ultrastructure in intrauterine growth restriction. Am J Obstet Gynecol. 2014 Jun;210(6):550.e1-7. doi: 10.1016/j.ajog.2014.01.023. Epub 2014 Jan 16. — View Citation
Ong KK, Ahmed ML, Emmett PM, Preece MA, Dunger DB. Association between postnatal catch-up growth and obesity in childhood: prospective cohort study. BMJ. 2000 Apr 8;320(7240):967-71. Erratum in: BMJ 2000 May 6;320(7244):1244. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular structure | Heart structure | 24 months | |
Primary | Cardiovascular function | Heart function | 24 months | |
Secondary | catch-up growth | delta between body weight at 24 months and birth weight | 24 months | |
Secondary | breastfeeding duration | breastfeeding duration | 24 months |
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