Measured cognitive outcomes for children exposed to GM-CSF compared with control children in the PROGRAMS trial groups at 5 years of age
| GM-CSF (n=79) | Control (n=78) | ||||
|---|---|---|---|---|---|
| Mean or no/total | % or SD | Mean or no/total | % or SD | Difference in means (95% CI) | |
| Cognitive development | |||||
| Kaufmann ABC | |||||
| Mental processing composite | 94 | (16) | 95 | (15) | −1 (−6 to 4) |
| <70 | 4/78 | 5% | 2/77 | 3% | |
| 70–85 | 9/78 | 12% | 18/77 | 23% | |
| Simultaneous processing | 95 | (17) | 95 | (16) | 0 (−5 to 5) |
| <70 | 6/78 | 8% | 2 | 3% | |
| 70–85 | 10/78 | 13% | 20 | 26% | |
| Sequential processing | 94 | (19) | 98 | (14) | −3 (−8 to 2) |
| <70 | 7/78 | 9% | 2 | 3% | |
| 70–85 | 4/78 | 5% | 13 | 17% | |
| Maths score | 99 | (14) | 97 | (13) | 1 (−3 to 5) |
| <70 | 3/78 | 4% | 5 | 6% | |
| 70–85 | 8/78 | 10% | 10 | 13% | |
| Riddles | 94 | (14) | 93 | (13) | 1 (−3 to 5) |
| <70 | 5/76 | 7% | 2/77 | 3% | |
| 70–85 | 11/76 | 14% | 18/77 | 23% | |
| Neuropsychological assessment (NEPSY) | Median | (IQR) | Median | (IQR) | Difference in medians (95% CI) |
| Sensorimotor component scaled scores | |||||
| Imitating hand positions | 7 | 5, 8 | 7 | 5, 9 | −0.2 (−1.1 to 0.8) |
| Visuomotor precision | 6 | 4, 9 | 7 | 5, 8 | −0.4 (−1.5 to 0.6) |
| Visuospatial component scaled score (2 of 4) | |||||
| Block construction | 8 | 7, 10 | 8 | 5, 10 | 0.9 (−1.6 to 3.5) |
| Design copying | 8 | 6, 10 | 8 | 6, 10 | 0.1 (−0.9 to 1.1) |
| Attention executive component (2 of 6) | |||||
| Visual attention scaled score | 10 | 8, 12 | 10 | 8, 12 | 0.1 (−3.3 to 3.5) |
| Statue total score | 23 | 14, 27 | 23 | 12, 27 | −0.2 (−4.1 to 4.1) |
| Language component scaled score (2 of 7) | |||||
| Phonological processing | 8 | 7, 10 | 9 | 6, 10 | 0.3 (−0.9 to 1.4) |
| Comprehension of instructions | 10 | 8, 12 | 10 | 8, 11 | −0.9 (−3.5 to 1.6) |
| Memory and learning component scaled score (4 of 5) | |||||
| Delayed memory for faces | 9 | 5, 13 | 10 | 4, 12 | 0.1 (−1.2 to 1.9) |
| Narrative memory | 8 | 6, 10 | 8 | 6, 10 | 0.3 (−0.8 to 1.4) |
| Delayed memory for names | 7 | 2, 9 | 8 | 3, 10 | −1.1 (−2.5 to 0.23) |
| Sentence repetition | 9 | 7, 11 | 9 | 7, 11 | 0.9 (−1.6 to 3.4) |
GM-CSF, granulocyte macrophage colony stimulating factor.