GM-CSF | Control | GM-CSF – control | ||||
---|---|---|---|---|---|---|
Outcome | Med (IQR) or n% | Med (IQR) or n% | Median difference (95% CI) | |||
Bayley scales of infant development | ||||||
Mental development index | n=90 | n=89 | ||||
Median (IQR) scores | 84 | (72–98) | 87 | (72–96) | 0 | (−4 to 5) |
Score <55 | 12 | 13% | 10 | 11% | ||
Score 55–69 | 7 | 8% | 6 | 7% | ||
Score 70–84 | 28 | 31% | 27 | 30% | ||
Score >84 | 43 | 48% | 46 | 52% | ||
Psychomotor development index | n=88 | n=90 | ||||
Median (IQR) scores | 85 | (73–96) | 88 | (77–100) | −3 | (−8 to 1) |
Score <55 | 9 | 10% | 11 | 12% | ||
Score 55–69 | 11 | 13% | 4 | 4% | ||
Score 70–84 | 24 | 27% | 19 | 21% | ||
Score >84 | 44 | 50% | 56 | 62% | ||
PARCA-r (parent report of child development) | (n=75) | (n=76) | ||||
Development | 26 | 22–29 | 26 | 23–29 | 0 | −1 to 2 |
Vocabulary | 46 | 25–68 | 38 | 16–68 | 7 | −3 to 17 |
Sentence complexity | 0 | 0–3 | 0 | 0–2 | 0 | 0 to 0 |
Parent report composite | 73 | 50–100 | 65 | 41–102 | 7 | −5 to 19 |
Parent report composite <49‡ | 17 | 24% | 25 | 34% | 0.7 | 0·4 to 1·2 |
Growth | Mean | (SD) | Mean | (SD) | Difference in means (95% CI) | ||
---|---|---|---|---|---|---|---|
Height | Cm | 85 | (5) | 84 | (4) | ||
SDS* | −1.6 | (1.4) | −1.7 | (1.1) | 0.1 | (−0.3 to 0.5) | |
Weight | Kg | 11 | (1.8) | 11 | (1.3) | ||
SDS | −1.7 | (1.4) | −1.8 | (1.2) | 0.0 | (−0.3 to 0.4) | |
Head circumference | Cm | 48 | (1.9) | 47 | (1.8) | ||
SDS | −2.1 | (1.5) | −2.1 | (1.4) | 0.1 | (−0.3 to 0.5) | |
Midupper arm circumference | Cm | 15 | (1.5) | 15 | (1.2) | ||
SDS† | −0.6 | (0·8) | −0.8 | (0.7) | 0.1 | (−0.1 to 0.4) | |
Abdominal circumference | Cm | 47 | (5.3) | 46 | (3.2) | 0.85 | (−0.5 to 2.2) |
↵* Height, weight, head circumference standard deviation scores (SDS) scores from child growth foundation standards.
↵† Midupper arm circumference standard deviation scores from WHO Expert committee.
↵‡ Parental questionnaire composite of non-verbal development, sentence complexity and vocabulary. Forty nine is the cut off for cognitive delay equivalent to bayley mental development index ≤70.
GM-CSF, granulocyte-macrophage colony-stimulating factor.