Subgroup | DQ18 scores | Distribution of developmental levels* | ||||||||||||
OLB6378 administration | Placebo administration | Mean difference | 95% CI | P value† | OLB6378 administration | Placebo administration | Partial correlation coefficient | 95% CI | P value‡ | |||||
n | Mean±SD | n | Mean±SD | n | Mean ± SD | n | Mean ± SD | |||||||
Gestational age | ||||||||||||||
<28 weeks | 30 | 89.4±11.6 | 28 | 90.8±12.3 | −1.4 | −7.7 to 4.9 | 0.657 | 43 | 2.8±1.1 | 34 | 2.7±1.0 | 0.23 | −0.585 to 1.046 | 0.580 |
≥28 weeks | 24 | 92.1±13.6 | 37 | 91.3±15.9 | 0.9 | −7.0 to 8.8 | 0.825 | 46 | 3.3±1.0 | 45 | 2.7±1.2 | 0.939 | 0.158 to 1.720 | 0.018 |
Birth weight | ||||||||||||||
<1000 g | 28 | 87.4±12.7 | 35 | 88.6±13.6 | −1.1 | −7.8 to 5.6 | 0.740 | 40 | 2.7±1.1 | 40 | 2.7±1.0 | −0.006 | −0.795 to 0.783 | 0.988 |
≥1000 g | 26 | 94.0±11.5 | 30 | 9.40±14.9 | 0.1 | −7.2 to 7.3 | 0.986 | 49 | 3.4±0.9 | 39 | 2.7±1.2 | 1.083 | 0.275 to 1.891 | 0.009 |
Light-for-dates | ||||||||||||||
Yes | 16 | 89.9±12.9 | 25 | 88.7±15.5 | 1.2 | −8.2 to 10.6 | 0.796 | 30 | 3.0±1.1 | 28 | 2.6±1.1 | 0.696 | −0.250 to 1.642 | 0.149 |
No | 38 | 90.9±12.5 | 40 | 92.6±13.6 | −1.6 | −7.5 to 4.3 | 0.584 | 59 | 3.1±1.1 | 51 | 2.8±1.1 | 0.532 | −0.154 to 1.218 | 0.129 |
Delivery | ||||||||||||||
Caesarean | 17 | 92.1±13.8 | 55 | 90.4±13.8 | 1.8 | −5.9 to 9.4 | 0.648 | 37 | 3.2±1.1 | 68 | 2.6±1.1 | 1.093 | 0.324 to 1.861 | 0.005 |
Vaginal | 37 | 89.9±12.0 | 10 | 94.9±17.3 | −4.9 | −14.4 to 4.6 | 0.301 | 52 | 2.9±1.0 | 11 | 3.1±0.9 | −0.26 | −1.454 to 0.934 | 0.669 |
Apgar score at 5 min | ||||||||||||||
≥8 | 36 | 90.7±13.0 | 27 | 94.1±14.6 | −3.4 | −10.3 to 3.6 | 0.339 | 66 | 3.1±1.1 | 31 | 2.9±1.1 | 0.518 | −0.268 to 1.305 | 0.197 |
<8 | 18 | 90.4±11.8 | 38 | 88.9±14.0 | 1.5 | −6.2 to 9.1 | 0.698 | 22 | 2.7±1.0 | 48 | 2.6±1.1 | 0.191 | −0.720 to 1.102 | 0.681 |
Antenatal steroid use | ||||||||||||||
Yes | 19 | 96.8±11.0 | 24 | 89.2±13.3 | 7.5 | −0.1 to 15.2 | 0.054 | 31 | 3.2±1.0 | 31 | 2.7±1.1 | 1.108 | 0.161 to 2.055 | 0.022 |
No | 35 | 87.3±12.1 | 41 | 92.1±15.0 | −4.9 | −11.2 to 1.4 | 0.129 | 58 | 2.9±1.1 | 48 | 2.8±1.1 | 0.331 | −0.363 to 1.025 | 0.350 |
Sex | ||||||||||||||
Male | 31 | 88.6±13.3 | 38 | 92.6±14.5 | −4.1 | −10.8 to 2.7 | 0.234 | 52 | 2.9±1.1 | 44 | 2.8±1.1 | 0.159 | −0.566 to 0.884 | 0.667 |
Female | 23 | 93.4±11.0 | 27 | 88.9±14.1 | 4.5 | −2.8 to 11.8 | 0.218 | 37 | 3.3±0.9 | 35 | 2.6±1.1 | 1.219 | 0.333 to 2.104 | 0.007 |
Total parenteral nutrition | ||||||||||||||
Yes | 53 | 90.2±12.2 | 62 | 90.6±14.3 | −0.4 | −5.4 to 4.5 | 0.862 | 75 | 2.9±1.0 | 70 | 2.7±1.0 | 0.376 | −0.216 to 0.968 | 0.213 |
No | 1 | 114 | 3 | 100.3±15.5 | – | – | – | 14 | 3.6±1.1 | 9 | 2.4±1.5 | 1.886 | −0.070 to 3.842 | 0.059 |
Age at enteral feeding of 100 mL/kg/day | ||||||||||||||
<13 days | 30 | 92.0±11.5 | 37 | 95.3±13.5 | −3.3 | −9.5 to 2.9 | 0.287 | 49 | 3.1±1.0 | 44 | 3.0±1.1 | 0.267 | −0.483 to 1.017 | 0.485 |
≥13 days | 24 | 88.9±13.7 | 28 | 85.5±13.8 | 3.5 | −4.2 to 11.2 | 0.369 | 40 | 2.9±1.1 | 35 | 2.4±1.1 | 0.996 | 0.154 to 1.837 | 0.020 |
*Developmental levels were determined in terms of the DQ18 scores, which were either computed or inferred (if developmental testing was unfeasible or unnecessary).
†Student’s t-test.
‡Ordered logistic regression analysis.
DQ18, developmental quotient at 18 months of corrected age.