Cardiovascular Screening in Infants Born Small for Gestational Age

NCT03758092 | Completed

• 1 other identifier: CE 106/18
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Abnormalities; Small-for-gestational Age

Outcome Measures

Primary Outcomes (2)

• Cardiovascular structure

  Heart structure

  24 months

• Cardiovascular function

  Heart function

  24 months

Secondary Outcomes (2)

• catch-up growth

  24 months

• breastfeeding duration

  24 months

Study Arms (1)

SGA vs AGA infants

infants, born at term (37+0/41+3 week gestation), aged 24 months, with a birth weight \<10th percentile or between 10th and 90th percentile for sex, gestational age, and birth order, according to Italian neonatal anthropometric charts

Eligibility Criteria

• Age: 24 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We consecutively enrolled 20 SGA infants, born at term (37+0-41+3 weeks gestation), aged 24 months, and 20 AGA, age- and sex-matched controls. SGA was defined as a birth weight \<10th percentile for sex, gestational age and birth order, and AGA as a birth weight between the 10th and the 90th percentile, according to Italian neonatal anthropometric charts

You may qualify if:

• infants, 24-month old, born at term SGA or AGA

You may not qualify if:

• heart, respiratory, liver and kidney diseases, congenital malformations, genetic diseases, neonatal asphyxia, parenteral nutrition, congenital inborn errors of metabolism, and preterm and twin birth.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica

Novara, 28100, Italy

Location

Related Publications (6)

• 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. doi: 10.1136/bmj.298.6673.564.

  PMID: 2495113 BACKGROUND

• 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. doi: 10.1136/bmj.320.7240.967.

  PMID: 10753147 BACKGROUND

• 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.

  PMID: 26861187 BACKGROUND

• 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.

  PMID: 24440565 BACKGROUND

• Crispi F, Bijnens B, Figueras F, Bartrons J, Eixarch E, Le Noble F, Ahmed A, Gratacos 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.

  PMID: 20497977 BACKGROUND

• 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.

  PMID: 23260106 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: September 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)