Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Enalapril	ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
Placebo	Placebo suspension

Participant Flow:   Overall Study

	Enalapril	Placebo
STARTED	115	115
COMPLETED	91	94
NOT COMPLETED	24	21
Death or Transplant	14	16
Family or MD withdrew subject	10	5

Reporting Groups

	Description
Enalapril	ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
Placebo	Placebo suspension

Baseline Measures

	Enalapril	Placebo	Total
Number of Participants   [units: participants]	115	115	230
Age   [units: participants]
<=18 years	115	115	230
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age   [units: days] Mean ± Standard Deviation	20.1  ± 8.9	20.7  ± 9.1	20.4  ± 9.0
Gender   [units: participants]
Female	40	28	68
Male	75	87	162
Race/Ethnicity, Customized   [units: participants]
White	96	89	185
Black/African-American	12	20	32
Asian	4	3	7
Other	3	3	6
Region of Enrollment   [units: participants]
United States	104	105	209
Canada	11	10	21

1.  Primary:

Weight-for-age Z-score at 14 Months of Age   [ Time Frame: Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age ]

2.  Secondary:

Height-for-age Z-score   [ Time Frame: Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age ]

3.  Secondary:

Head Circumference-for-age Z-score   [ Time Frame: Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age ]

4.  Secondary:

Number of Participants With Ross Heart Failure Class I   [ Time Frame: Just prior to the pre-Glenn surgery ]

5.  Secondary:

Number of Participants With Ross Heart Failure Class I   [ Time Frame: Measured at 14 months of age ]

6.  Secondary:

B-Type Natriuretic Peptide   [ Time Frame: Measured just prior to the Glenn surgery ]

7.  Secondary:

B-type Natriuretic Peptide Level   [ Time Frame: at the time of the 14 month visit ]

8.  Secondary:

Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score   [ Time Frame: at 14 months of age ]

9.  Secondary:

Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score   [ Time Frame: at 14 months of age ]

10.  Secondary:

Neurodevelopmental Status (FSII)   [ Time Frame: at 14 months of age ]

11.  Secondary:

MacArthur-Bates Inventory -Phrases Understood   [ Time Frame: at 14 months of age ]

12.  Secondary:

MacArthur-Bates Inventory -Words Understood   [ Time Frame: at 14 months of age ]

13.  Secondary:

MacArthur-Bates Inventory -Total Gestures   [ Time Frame: at 14 months of age ]

14.  Secondary:

MacArthur-Bates Inventory -Words Produced   [ Time Frame: at 14 months of age ]

15.  Secondary:

Ejection Fraction (%)   [ Time Frame: just before the Glenn surgery ]

16.  Secondary:

Ejection Fraction (%)   [ Time Frame: at 14 months of age ]

17.  Secondary:

Ventricular Mass   [ Time Frame: just before the Glenn surgery ]

18.  Secondary:

Ventricular Mass   [ Time Frame: At 14 months of age ]

19.  Secondary:

Ventricular Mass Z-score   [ Time Frame: just before the Glenn surgery ]

20.  Secondary:

Ventricular Mass Z-score   [ Time Frame: at 14 months of age ]

21.  Secondary:

End-diastolic Volume   [ Time Frame: just before the Glenn surgery ]

22.  Secondary:

End-diastolic Volume   [ Time Frame: at 14 months of age ]

23.  Secondary:

End Diastolic Volume Z-score   [ Time Frame: just before the Glenn surgery ]

24.  Secondary:

End-diastolic Volume Z-score   [ Time Frame: at 14 months of age ]

25.  Secondary:

Ventricular Mass to Volume Ratio   [ Time Frame: Measured just before the Glenn surgery ]

26.  Secondary:

Ventricular Mass to Volume Ratio   [ Time Frame: Measured at 14 months of age ]

27.  Secondary:

Ventricular Filling Pressure   [ Time Frame: just before the Glenn surgery ]

28.  Secondary:

Number of Participants With Moderate to Severe AV Valve Regurgitation   [ Time Frame: just before the pre-Glenn surgery ]

29.  Secondary:

Number of Participants With Moderate to Severe AV Valve Regurgitation   [ Time Frame: at age 14 months ]