Characteristics of the study sample.

<p>Data are expressed as mean ± SD and [range], or median and (25–75 percentile)</p><p>ASQ3: Ages and Stages Questionnaire, Third Edition</p><p>BSIDIII: Bayley Scales of Infant and Toddler Development, Third Edition</p><p>Characteristics of the study sample.</p

Flowchart with numbers of eligible and included children.

<p>ASQ3; Ages and Stages Questionnaire, Third Edition, time window 22–26 months corrected age. BSIDIII: Bayley Scales of Infant and Toddler Development, Third Edition, time window 21–30 months corrected age. NDI: Neurodevelopmental Impairment: BSIDIII cognitive score or composite motor score <70, bilateral blindness/deafness or cerebral palsy.</p

ROC curve for NDI with BSIDIII threshold< 70 versus ASQ3 total scores.

<p>Area under the curve 96% p<0.0001</p

Correlation between BSIDIII combined cognitive and composite motor scores and ASQ3 total scores.

<p>R square is 0.417, p<0.001. Incomplete BSID scores due to CP or severe mental impairment were imputed at 50 and incomplete ASQ scores were imputed with 0 points per item without a valid score.</p

ASQ3 failures and the domains for different NDI thresholds.

<p>Data are presented as numbers and percentages.</p><p>ASQ3: Ages and Stages Questionnaire, Third edition.</p><p>Failure ASQ3: a score of >2 SD below the mean score for the U.S. reference group on any domain</p><p>BSIDIII: Bayley Scales of Infant and Toddler Development, Third Edition.</p><p>NDI with BSIDIII<70: neurodevelopmental impairment with BSIDIII cognitive score or composite motor score of <70, bilateral blindness/deafness and/or cerebral palsy.</p><p>NDI with BSIDIII<80: neurodevelopmental impairment with BSIDIII cognitive score or composite motor score of <80, bilateral blindness/deafness and/or cerebral palsy.</p><p>NDI with BSIDIII<85: neurodevelopmental impairment with BSIDIII cognitive score or composite motor score of <85, bilateral blindness/deafness and/or cerebral palsy.</p><p>ASQ3 failures and the domains for different NDI thresholds.</p

ASQ3 total scores for children with No NDI and children with NDI.

<p>NDI with BSID threshold set at < 70. Incomplete BSIDIII scores due to CP or severe mental impairment were imputed at 50 and incomplete ASQ3 scores were imputed with 0 points per item without a valid score.**** <i>p</i>< 0.0001</p

Outcomes at 18 to 24 months.

<p>Plus-minus values are means ± standard deviations. The denominator used to calculate the percentage of infants with a specific outcome was the number of infants randomly assigned to each treatment group for whom that outcome was known at 18 to 24 months. This number was the total number in each group, unless otherwise specified. The motor and cognitive scores were assessed with the BSID III (scores range from 50 to 150, where 150 indicates most advanced development).</p><p>The relative risk of each outcome was calculated for the BA ratio group as compared to the TSB group. In the B/A ratio group the mean (±SD) age at death was 30±16 days and 10±7 days in the TSB group. Severe NDI was a composite motor score of <70, a composite cognitive score of <70, moderate or severe cerebral palsy, severe unilateral or bilateral hearing loss, or unilateral or bilateral blindness. Neurodevelopmental impairment was a composite motor score of <85, a composite cognitive score of <85, any neurological impairment, any visual impairment, or hearing impairment.</p><p>P value#: Outcomes of t-test for continuous variables or Fischer exact test for categorical variables, two-tailed; RR is relative risk with (95% confidence interval). P value ^$: corresponding P value.</p

Baseline characteristics at randomization.

<p>Plus-minus values are means ± standard deviations. The denominator used to calculate the percentages of infants or mothers with a specific characteristic was the number for whom the characteristic was known. This number was the total number in each group, unless otherwise specified. No significant differences were found between the two groups. # Race or ethnicity was reported by patients' parents or guardians or determined by the physician on reviewing the charts.</p