Cardiovascular Screening in Infants Born Small for Gestational Age (CardioSGA)

November 28, 2018 updated by: Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita

Cardiovascular Screening in 2-year Old Infants Born Small for Gestational Age Compared With Infants Born Adequate for Gestational Age

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.

Study Overview

Status

Completed

Conditions

Detailed Description

We consecutively enrolled 20 SGA infants, born at term (37+0/41+3 week 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.

Clinical and anthropometric variables The infants' prenatal and neonatal data were retrospectively recorded, namely a history of gestational diabetes and hypertension, the presence of intrauterine growth restriction, maternal weight gain during pregnancy, Apgar score, gestational age and birth weight, length, and head circumference. All subjects' parents completed a questionnaire including family history, maternal smoking during pregnancy, breastfeeding duration. At the time of enrollment (24 months), anthropometric data were evaluated by trained physicians according to standard procedures and based on the WHO growth charts. Height, weight, systolic (SBP) and diastolic (DBP) blood pressure were measured. Body mass index (BMI) was calculated as weight (kg)/height(cm)2 and weight gain in the first 2 years of life was calculated as the delta between birth weight and weight at 24 months.

Echocardiographic assessment Transthoracic echocardiogram using a Vivid 7 Pro ultrasound scanner (General Electric Healthcare, USA) was performed by an expert pediatric cardiologist, blinded to patients' clinical data. Measurements of left ventricle (LV end-diastolic diameter, LVEDD; LV end-systolic diameter, LVESD; interventricular septum at end diastole, IVSD; LV posterior wall at end diastole, LVPWD), relative wall thickness (RWT), left atrium diameter (LAD), the maximum LA volume, LV ejection fraction, and tricuspid annular plane systolic excursion (TAPSE) were obtained according to established standards. LV mass (LVM) was derived from the Devereux formula and indexed to body surface area (left ventricular mass index, LVMI). Left ventricular output (LVO) was obtained with the velocity time integral (VTI) from a 5-chamber view and calculated as follows LVO=[(VTI)x(heart rate)x(cross-sectional area)] and indexed to body weight.

Using pulsed wave Doppler, mitral inflow velocities, peak early diastolic velocity (E), peak late diastolic velocity (A), and E/A ratio, were measured. Pulsed wave tissue Doppler of the lateral mitral annulus was used for the measurement of early peak diastolic mitral annular velocity (E'). The E/E' ratio was calculated. End-diastolic pressure (EDP) was calculated from the E/E' ratio with the formula EDP=1.91+1.24xE/E' (14) and the pressure-volume curve during diastole with the formula EDP = αxEDVβ (end-diastolic volume, EDV). Volume parameters were corrected to fixed values of EDP (V30 mmHg). The coefficient "β" (Beta), indicating the slope of the end-diastolic pressure-volume relationship (EDPVR), was calculated with the formula β=[Log10(EDP/30)]/[Log10(EDV/V30mmHg)].

Vascular assessment Vascular measurements were performed with a high-resolution ultrasonography (Esaote MyLab25TM Gold, Esaote, Italy) using a 8 mHz linear transducer and a 5 mHz convex transducer for the abdominal aorta, by an expert vascular surgeon blinded to patients' clinical status. CIMT, abdominal aortic diameter at maximum systolic expansion (Ds) and minimum diastolic expansion (Dd), brachial artery diameters, brachial artery peak systolic velocity (PSV) and end diastolic velocity (EDV) were measured as previously described and aortic strain (S), pressure strain elastic modulus (Ep), pressure strain normalized by diastolic pressure (Ep*) and brachial artery flow-mediated dilation (FMD) were calculated. While S is the mean strain of the aortic wall, Ep and Ep* are the mean stiffness (16). Arterial wall stiffness index (β index) was calculated with the formula: β index=ln(SBP/DBP)/[(Ds-Dd) /Dd)] (17) and systemic vascular resistance (dynes/s/cm2) with the formula: SVR=(mean BP- right atrial pressure)/LVO, with an estimated right atrial pressure of 5 mmHg. The brachial artery maximum diameter recorded following reactive hyperemia was reported as a percentage change of resting diameter (FMD = peak diameter - baseline diameter/baseline diameter).

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular structure
Time Frame: 24 months
Heart structure
24 months
Cardiovascular function
Time Frame: 24 months
Heart function
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
catch-up growth
Time Frame: 24 months
delta between body weight at 24 months and birth weight
24 months
breastfeeding duration
Time Frame: 24 months
breastfeeding duration
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 106/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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