Table 2

Outcomes at the 18-month medical check-up

Outcome	OLB6378 administration (n=102)		Placebo administration (n=105)		Regression analysis*
Outcome	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 O₂, 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.