Table 2.
Outcomes at 2 years in babies randomized to dextrose or placebo gel
| Randomized to Dextrose Gel | Randomized to Placebo Gel | Relative risk or mean difference (95% CI) | p value | |||
|---|---|---|---|---|---|---|
| n = 90 | n = 94 | |||||
| n | n | |||||
| Age at assessment (months) | 90 | 24.2 ± 1.2 | 94 | 24.5 ± 1.9 | −0.31 (−0.77 – 0.15) | 0.18 |
| Primary outcomes | ||||||
| Neurosensory impairment | 90 | 34 (38%) | 94 | 32 (34%) | 1.11 (0.75 – 1.63) | 0.60 |
| None | 56 (62%) | 62 (66%) | ||||
| Mild | 28 (31%) | 31 (33%) | ||||
| Moderate | 5 (6%) | 1 (1%) | ||||
| Severe | 1 (1) | 0 (0%) | ||||
| Processing difficulty | 84 | 8 (10%) | 87 | 16 (18%) | 0.52 (0.23 – 1.15) | 0.10 |
| Secondary Outcomes | ||||||
| Developmental delay | 90 | 31 (34%) | 93 | 30 (32%) | 1.07 (0.71 – 1.61) | 0.75 |
| None | 59 (66%) | 63 (68%) | ||||
| Mild | 25 (28%) | 29 (31%) | ||||
| Moderate | 5 (6%) | 1 (1%) | ||||
| Severe | 1 (1%) | 0 (0) | ||||
| Cerebral Palsy | 2 (2%) | 0 (0) | ||||
| Bayley-III Composite scores | ||||||
| Cognitive | 90 | 93 ± 11 | 93 | 94 ± 9 | −1.30 (−4.21 – 1.61) | 0.38 |
| Language | 89 | 96 ± 14 | 93 | 96 ± 13 | −0.72 (−3.14 – 4.58) | 0.71 |
| Motor | 90 | 99 ± 10 | 93 | 99 ± 9 | −0.36 (−3.04 – 2.33) | 0.80 |
| Social emotional | 88 | 105 ± 15 | 90 | 104 ± 16 | −0.43 (−4.12 – 4.99) | 0.85 |
| General adaptive | 89 | 101 ± 13 | 91 | 99 ± 14 | 1.34 (−2.70 – 5.38) | 0.52 |
| Executive function | 87 | 92 | ||||
| Composite score | 10.9 ± 4.1 | 10.0 ± 4.0 | 0.93 (−0.24 – 2.11) | 0.12 | ||
| Children with z-score < −1.5 | 5 (6%) | 8 (9%) | 0.66 (0.22 – 1.94) | 0.45 | ||
| Brief-P Index scores | 89 | 93 | ||||
| Inhibitory Self Control | 55 ± 11 | 54 ± 10 | 1.09 (−1.88 – 4.06) | 0.47 | ||
| Flexibility | 52 ± 10 | 52 ± 10 | 0.24 (−2.67 – 3.15) | 0.87 | ||
| Emergent Metacognition | 60 ± 12 | 58 ± 12 | 2.17 (−1.26 – 5.60) | 0.21 | ||
| Global Executive Composite | 58 ± 11 | 56 ± 11 | 1.71 (−1.48 – 4.89) | 0.29 | ||
| Vision | 86 | 89 | ||||
| Motion coherence threshold | 40.2 ± 12.8 | 41.5 ± 15.7 | −1.31 (−5.55 – 2.93) | 0.55 | ||
| Children with z-score > 1.5 | 4 (5%) | 8 (9%) | 0.52 (0.16 – 1.66) | 0.27 | ||
| Vision problem | 90 | 26 (29%) | 93 | 23 (25%) | 1.17 (0.72 – 1.89) | 0.53 |
| Refractive error | 51 | 3 (6%) | 49 | 5 (10%) | 0.58 (0.15 – 2.28) | 0.43 |
| Anthropometry (z-scores) | ||||||
| Weight | 89 | 0.79 ± 1.10 | 91 | 0.52 ± 0.99 | 0.26 (−0.04 – 0.57) | 0.09 |
| Height | 90 | −0.01 ± 1.09 | 90 | −0.24 ± 1.17 | 0.24 (−0.09 – 0.57) | 0.16 |
| BMI | 89 | 1.12 ± 1.12 | 90 | 0.96 ± 0.84 | 0.16 (−0.13 – 0.45) | 0.27 |
| Head circumference | 90 | 0.86 ± 1.05 | 94 | 0.83 ± 1.21 | 0.03 (−0.30 – 0.35) | 0.88 |
| Arm circumference | 90 | 1.08 ± 1.00 | 91 | 0.92 ± 0.97 | 0.15 (−0.13 – 0.44) | 0.29 |
| Seizures | 90 | 4 (4%) | 91 | 5 (5%) | ||
Data are number (%), or mean ± SD