Table 2. World Health Organization Growth Z-scores by Treatment Assignment*.
| Enalapril | Placebo | Difference† | P Value§ | |
|---|---|---|---|---|
|
Predicted Means at Age 14 months based on Longitudinal Modeling
‡
| ||||
| Variable | Predicted mean±SE (no. of patients) |
Predicted mean±SE (95% CI) |
||
|
| ||||
| Weight-for-age z-score | −0.62±0.13 (91) | −0.42±0.13 (94) | −0.20±0.18 (−0.56 to 0.16) |
0.28 |
| Weight-for-height z-score | −0.18±0.13 (91) | −0.08±0.13 (94) | −0.11±0.18 (−0.47 to 0.25) |
0.55 |
| Height-for-age z-score | −1.00±0.13 (91) | −0.86±0.13 (94) | −0.14±0.18 (−0.50 to 0.21) |
0.42 |
| Head circumference-for-age z-score | −0.55±0.17 (91) | 0.09±0.17 (94) | −0.64±0.24 (−1.11 to −0.17) |
0.008 |
|
| ||||
|
Raw Means at Pre-SCPC Surgery and Final Study Visits
**
| ||||
| Variable | Mean±SD (no. of patients) | Mean±SD (95% CI) | ||
|
| ||||
| Pre-SCPC Surgery Visit †† | ||||
|
| ||||
| Weight-for-age z-score | −1.60±1.16 (97) | −1.66±1.12 (100) | 0.07±1.14 (−0.25 to 0.39) |
0.69 |
| Weight-for-height z-score | −0.88±1.18 (97) | −1.03±1.28 (100) | 0.14±1.23 (−0.20 to 0.49) |
0.42 |
| Height-for-age z-score | −1.30±1.37 (97) | −1.28±1.17 (100) | −0.02±1.27 (−0.37 to 0.34) |
0.93 |
| Head circumference-for-age z-score | −1.49±1.33 (97) | −1.32±1.05 (99) | −0.17±1.20 (−0.51 to 0.17) |
0.32 |
|
| ||||
| Final Study Visit | ||||
|
| ||||
| Weight-for-age z-score | −0.54±1.09 (91) | −0.43±1.13 (94) | −0.11±−0.1.11 (−0.44 to 0.21) |
0.49 |
| Weight-for-height z-score | −0.16±1.04 (91) | −0.00±1.16 (94) | −0.16±1.10 (−0.48 to 0.16) |
0.34 |
| Height-for-age z-score | −0.92±1.20 (91) | −0.94±1.13 (94) | 0.02±1.16 (−0.32 to 0.35) |
0.92 |
| Head circumference-for-age z-score | −0.40±1.28 (91) | 0.09±1.59 (94) | −0.48±1.44 (−0.90 to −0.06) |
0.02 |
CI- confidence interval, SE- standard error, SD- standard deviation, SCPC- superior cava pulmonary connection.
Difference was defined as the mean for the enalapril group minus the mean for the placebo group.
P values for predicted means were calculated using a contrast of the estimated group means at 14 months and their associated standard errors from longitudinal modeling. P values for raw means were based on the two-sample t-test (inferences were similar with the use of a Wilcoxon rank-sum test, and after adjustment for gestational age). P values are unadjusted for the one interim look at the data.
The data from all 230 subjects were used in longitudinal analysis (see Methods).
All mean z-scores differ from zero (the normal population mean), P<0.05 by one-sample t-test with three exceptions, all at the final study visit: weight-for-height z-score for both treatment arms and head circumference-for-age z-score for the placebo group are not significantly different from zero.
Weight measurements were not available in 1 patient in the enalapril group and 2 patients in the placebo group at the pre-SCPC visit.