Outcome | OLB6378 administration (n=102) | Placebo administration (n=105) | Regression analysis* | |||||

n | n (%) Mean±SD | n | n (%) Mean±SD | Partial correlation coefficient | OR | 95% CI | P values | |

Body weight, kg | 98 | 9.3±1.7 | 103 | 9.2±1.2 | 0.177† | − 0.277 to 0.581 | 0.390 | |

Body length, cm | 97 | 77.1±4.3 | 103 | 77.2±4.2 | −0.148† | −1.333 to 1.038 | 0.806 | |

Head circumference, cm | 80 | 46.3±2.2 | 93 | 46.5±1.8 | −0.259† | −0.864 to 0.347 | 0.401 | |

Use of O_{2}, n (%) | 102 | 6 (6) | 102 | 6 (6) | 1.000‡ | 0.311 to 3.210 | 1.000 | |

Cerebral palsy, n (%) | 100 | 4 (4) | 100 | 10 (10) | 0.375‡ | 0.114 to 1.238 | 0.108 | |

Developmental test | 89 | 79 | ||||||

DQ18 score | 54 | 90.6±12.5 | 65 | 91.1±14.4 | −0.443† | −5.384 to 4.499 | 0.859 | |

Distribution of developmental levels§ | 89 | 3.0±1.1 | 79 | 2.7±1.1 | 0.589¶ | 0.034 to 1.144 | 0.038 | |

DQ18 score <85 or developmental test was unfeasible, n (%) | 89 | 24 (27) | 79 | 32 (41) | 0.542‡ | 0.283 to 1.038 | 0.065 |

Use of O

_{2,}use of oxygen postdischarge (this include all discharged for home oxygen).*Treatment effect.

†Linear regression analysis.

‡Logistic regression analysis.

§Developmental levels were determined in terms of the DQ18 scores, which were either computed or inferred (if developmental testing was unfeasible or unnecessary).

¶Ordered logistic regression analysis.

DQ18, developmental quotient at 18 months of corrected age.