Table 5.
Neurodevelopmental outcomes at 24 month corrected age in VLBW infants
| Outcome | Lactoferrin | Placebo | |
|---|---|---|---|
| Mullena, mean (SD) | (n=80) | (n=85) | Adjusted difference (95% CI) |
| Composite | 83.5 (14.4) | 81.8 (12.3) | 1.59 (−7.12 – 10.30) |
| Gross Motor | 41.6 (7.0) | 41.7 (7.6) | −0.09 (−2.20 – 2.01) |
| Visual Reception | 43.7 (9.3) | 42.0 (8.7) | 1.68 (−4.25 – 7.61) |
| Fine Motor | 42.0 (10.1) | 42.8 (9.1) | −0.80 (−4.43 – 2.83) |
| Receptive Language | 44.7 (11.9) | 43.5 (12.2) | 1.23 (−5.20 – 7.66) |
| Expressive Language | 34.3 (7.7) | 33.2 (7.3) | 1.13 (−5.67 – 7.92) |
| Composite combined (12, 18 and 24 months)b, mean | 84.1 | 85.2 | −1.34 (−3.40 – 0.73) |
| Bayleya, mean (SD) | (n=63) | (n=66) | Adjusted difference (95% CI) |
| Cognitive | 94.3 (9.2) | 94.5 (6.8) | −1.22 (−2.87 – 0.43) |
| Language | 86.0 (10.6) | 85.6 (10.0) | 0.37 (−5.78 – 6.52) |
| Motor | 95.4 (12.5) | 96.9 (11.3) | −1.44 (−2.89 – 0.01) |
| Social emotional score | 113.2 (18.4) | 111.7 (18.1) | 1.45 (−0.78 – 3.67) |
| Neurodevelopmental delaya | n/N (%) | n/N (%) | Relative risk (95% CI) |
| Mullen Composite ≤70 | 15/80 (18.8) | 18/85 (21.2) | 0.89 (0.40 – 1.95) |
| Bayley Cognitive <85 | 6/63 (9.5) | 4/66 (6.1) | 1.57 (0.54 – 4.61) |
| Bayley Language <85 | 27/61 (44.3) | 25/65 (38.5) | 1.15 (0.72 – 1.84) |
| Bayley Motor <85 | 8/62 (12.9) | 7/65 (10.8) | 1.20 (0.84 – 1.71) |
| ABAS-II, GAC <70 | 24/59 (40.7) | 21/64 (32.9) | 1.24 (0.86 – 1.80) |
| M-CHAT-R, Score ≥3c | 9/72 (12.5) | 8/72 (11.1) | 1.13 (0.81 – 1.56) |
Abbreviations: Mullen, Mullen Scales of Early Learning (MSEL); SD, standard deviation; Bayley-III, Bayley Scales of Infant and Toddler Development Third Edition (BSID-III); ABAS-II, Adaptive Behavior Assessment System Second Edition; GAC, general adaptive composite; M-CHAT-R, Modified Checklist for Autism in Toddlers-Revised
a
Adjusted for hospital and weight category (≤1000 g, 1001–1500 g, 1501–2000 g), excluding patients with cerebral palsy (5, LF; 7, placebo). Corrected age is reported for all outcomes.
b
Generalized estimating equations.
c
Medium to high risk for autism spectrum disorder (ASD).