Methodology

This study was a case-control study. The study was done at the pediatric
department in Prince Hamza Hospital, Amman, Jordan, over a one-year
period from September 2021 to September 2022. Aiming to determine the
risk factors associated with congenital heart defects in Jordan.

Population

The target population was pediatric patients admitted to Prince Hamza

Hospital or visiting the pediatric clinic from September 2021 to September
2022.

Sampling

For the Cases group, pediatrics with confirmed diagnosis by a pediatric

cardiologist and on echocardiography were recruited. As for the controls,
they were recruited from pediatrics who were either admitted to Prince
Hamza Hospital or visiting the pediatric clinic for reasons other than
congenital heart defects and not suspected of having a heart defect on
history and clinical examination (without subjecting them to
echocardiography).

Inclusion criteria for both cases and controls were pediatric patients
admitted to Prince Hamza Hospital or visiting the pediatric clinic. Exclusion
criteria for both cases and controls were children whose parents did not
give consent of participating in the study, cases of acquired heart disease,
and patients with insufficient data regarding risk factors. Convenience
sampling was used to select both cases and controls.
A sample size of "400" was included with a ratio of 1:1 for the number of
cases to the number of controls.

The data was collected through a questioner which was filled in person.
The questioner constituted of several parts taking into account the
socioeconomic status, antenatal and maternal history, and a section
dedicated to the child’s birth data and their condition.
The risk factors (for both cases and controls) analyzed were the age of the
parents, consanguinity, any drug intake, bad obstetrics history, maternal
illnesses, any systemic illness in the mother, the parents’ smoking history,
and others.

Tools

We calculated the sample size based on the expected correlation between

macronutrients and empathy. To have 95% confidence intervals, and a 5%
margin of error, and thus this study should include at least 370 participants,
185 cases, and 185 controls. The sample size was calculated by the online
calculator "Sample Size Calculators" for designing clinical research.
Descriptive statistics was performed to report the analysis of data that was
presented as mean ± standard deviation or median (25th–75th percentile) -
depending on the normality test. However, categorical variables are shown
as frequency and percentages. Further, the independent t-test was used to
compare the parametric variables. Moreover, categorical variables were
compared by using the chi-square test. Also, Pearson's or Spearman's
correlations were used to determine the strength of the relationship
between the variables. The Kruskal–Wallis test was used to compare more
than two independent groups for cases with abnormally distributed
variables. In cases where the Kruskal–Wallis test yielded statistical
significance, a post hoc analysis was performed to identify the groups that
showed differences by using a Tukey. P values ˂0.05 were regarded as
statistically significant.
However, if the normality test reveals that the variables are normally
distributed, the ANOVA test will be used instead Kruskal-Wallis test. Odd’s
Ratio and logistic regression analyses were conducted to examine how
independent variables (The Risk factors) predicted the dependent variable
(Congenital heart disease). The data analysis was performed using SPSS
version 25 for Windows.