Table 2.

Infant Single Ventricle Trial Baseline Characteristics by Screening Status

	Eligible
Characteristic	Ineligible	Not Enrolled	Enrolled	P-value*
N	712	303	230
Mean Age at Screening, Days	11.9 ± 11.1	11.3 ± 8.4	13.8 ± 9.2	<.001
Male	11.8 ± 11.3	11.3 ± 7.5	13.2 ± 8.0	0.028
Female	12.0 ± 10.9	11.2 ± 9.7	15.4 ± 11.4	0.008
Median (Q1,Q3) Age at Screening, Days	8.0 (4.0, 15.5)	10.0 (5.0, 14.0)	13.0 (8.0, 17.0)	<.001
Male	8.0 (4.0, 15.0)	10.0 (6.0, 14.5)	13.0 (8.0, 16.0)	0.008
Female	9.0 (4.0, 16.0)	9.0 (4.0, 14.0)	12.5 (6.5, 22.0)	0.010
Male	58%	61%	70%	0.022
Race				0.096
White	74%	72%	80%
Black or African American	18%	18%	14%
Asian	4%	4%	3%
Other	4%	6%	3%
Hispanic	18%	14%	15%	0.703
Gestational Age <37 weeks	22%	9%	9%	0.879
Median (Q1,Q3) Gestational Age, Weeks**	38.0 (37.0, 39.0)	39.0 (38.0, 40.0)	38.0 (37.0, 39.0)	0.212
Mean Birth Weight, kg	2.9 ± 0.7	3.2 ± 0.5	3.3 ± 0.5	0.283
Male	3.0 ± 0.7	3.3 ± 0.5	3.3 ± 0.5	0.383
Female	2.8 ± 0.7	3.2 ± 0.4	3.2 ± 0.5	0.948
Single Ventricle Anatomic Diagnosis				0.168
Single Ventricle	33%	36%	29%
Hypoplastic Left Heart	42%	54%	63%
Other Functional SV	23%	9%	8%
Unclassified	2%	0.3%	0.4%
At least 1 Associated Anatomic Diagnosis	53%	50%	46%	0.370
Type of Surgery				0.138
Norwood	48%	66%	72%
Systemic-to-Pulmonary Shunt	25%	21%	17%
Pulmonary artery Band	6%	7%	6%
Damus-Kaye-Stansel	1%	1%	3%
Other	20%	5%	2%
Median number of concurrent surgeries	0.0 (0.0, 1.0)	0.0 (0.0, 1.0)	0.0 (0.0, 1.0)	0.317
Median number of interventional cardiac catheterizations: birth to screening	0.0 (0.0, 0.0)	0.0 (0.0, 0.0)	0.0 (0.0, 0.0)	0.116
Median number of other cardiac surgeries: post-palliation to screening	0.0 (0.0, 1.0)	0.0 (0.0, 1.0)	1.0 (0.0, 1.0)	0.061

^*Test of significance for differences between enrolled patients and eligible but not enrolled patients. Exact test for categorical variables and t-test or Wilcoxon rank sum test for continuous variables

^**Gestational age imputed as 40 weeks for 72 full-term patients.