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Comparison Between Lactoferrin and Placebo Groups in Neonatal Study

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Table S1. Supplementary information on the comparison between Lactoferrin and Placebo Groups

Lactoferrin Placebo p

Demographic and clinical characteristics

Maternal age in years, mean ± SD 30.7 ± 6. 9 30.0 ± 6.6 0.450

Obstetric complications, n/total (%) 87/95 (92.6) 88/94 (93.6) 0.782

Preeclampsia or eclampsia 18/95 (19.0) 28/95 (29.5) 0.127

Multiple pregnancy 23/95 (24.2) 15/95 (15.8) 0.204

Antenatal steroids, n/total (%) 57/94 (60.6) 56/89 (62.9) 0.763

Clear amniotic fluid, n/total (%) 80/86 (93.0) 78/91 (85.7) 0.147

Male sex, n/total (%) 42/95 (44.2) 50/95 (52.6) 0.310

APGAR Score at 5min, mean ± SD 8.4 ± 1.0 8.5 ± 1.1 0.842

Mother education, # of years, mean ± SD 11.5 ± 2.8 12.0 ± 2.3 0.193

Fathers education, # of years, mean ± SD 12.5 ± 2.5 12.0 ± 2.3 0.164

Total # of household members, mean ± SD (range) 4.5 ± 2.6 (2 – 15) 4.4 ± 2.7 (2 – 16) 0.798

Hospital enrollee distribution, n/total (%) 0.788

Cayetano 13/95 (13.7) 15/95 (15.8)

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Almenara 28/95 (29.5) 24/95 (25.3)

Sabogal 54/95 (56.8) 56/95 (59.0)

Risk factors for late-onset sepsis and nutritional characteristics (first month of life or until discharge or withdrawal) Duration of hospitalization in days, median (range) 16 (3 – 31) 20 (3 – 32) 0.324 Duration of stay in NICU in days, mean ± SD (range) 7.3 ± 9.2 (0 – 30) 7.9 ± 9.5 (0 – 29) 0.659

Use of TPN in days, mean ±SD 3.3 ± 5.4 3.0 ± 4.9 0.715

Use of catheters in days, mean ± SD 12.9 ± 9.4 14.8 ± 9.6 0.179

Umbilical catheter positioned 1.4 ± 3.2 1.4 ± 3.1 0.964

Assisted ventilation in days, mean ± SD 3.8 ± 7.1 4.6 ± 8.1 0.490

Supplemental O2 (nasal canula, hood, CPAP) 3.1 ± 6.1 3.5 ± 6.6 0.641

Medication, days treated, mean ± SD

H2 Blockers 0.5 ± 1.8 0.5 ± 1.5 0.966

Vasopressors and inotropes 0.2 ± 0.7 0.4 ± 2.1 0.437

NICU, neonatal intensive care unit; TPN, total parenteral nutrition; *Lactoferrin: 1547 child-days; Placebo: 1697 child-days of observation.

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