PROGRAMS: infant and maternal characteristics at trial entry and short term outcomes for all children followed-up at 2 years age corrected for prematurity
| GM-CSF (n=101) | Control (n=102) | |||||
|---|---|---|---|---|---|---|
| n or median | % or IQR | n or median | % or IQR | Difference or RR | 95% CI for difference or RR | |
| Characteristics at trial entry | ||||||
| Male, n (%) | 46 | 46% | 50 | 49% | 0.9 | 0.7 to 1.2 |
| Age at recruitment, h, median (IQR) | 43 | 24–60 | 46 | 28–63 | −4 | −10 to 1 |
| Gestational age, weeks, median (IQR) | 29 | 27–30 | 29 | 27–30 | 0.1 | −0.3 to 0.7 |
| Birthweight, g, median (IQR) | 839 | 668 to 932 | 788 | 630–928 | 19 | −34 to 70 |
| Neutrophil count at trial entry, ×109/l, median (IQR) | 2.7 | 1.3–4.1 | 2.6 | 1.3–4.3 | 0 | −0.6 to 0.5 |
| Neutropaenia (<1.1×109/l) at trial entry, n (%) | 16/97 | 16% | 18/97 | 19% | 0.9 | 0.5 to 1.6 |
| Multiple pregnancies, n (%) | 27 | 27% | 22 | 22% | 1.2 | 0.8 to 2.0 |
| Maternal antenatal steroids administered 4 h or more before delivery, n (%) | 80/87 | 92% | 83/88 | 94% | 1.0 | 0.9 to 1.1 |
| Infants given surfactant within 4 h of birth, n (%) | 70/79 | 89% | 76/82 | 93% | 1.0 | 0.9 to 1.1 |
| Cranial ultrasound findings at trial entry | ||||||
| Normal | 76/100 | 76% | 82/97 | 85% | ||
| Minor abnormality | 21/100 | 21% | 12/97 | 12% | ||
| Severe abnormality | 3/100 | 3% | 3/97 | 3% | ||
| Short-term outcomes | ||||||
| Necrotising enterocolitis (confirmed at surgery or post mortem) | 2 | 2% | 4 | 4% | 0.5 | 0.1 to 2.7 |
| Sepsis: culture positive to day 28 from trial entry | 26 | 26% | 22 | 22% | 1.2 | 0.7 to 2.0 |
| Sepsis: culture positive and probable to day 28 | 29 | 29% | 34 | 33% | 0.9 | 0.6 to 1.3 |
| Cranial ultrasound findings | ||||||
| Normal | 62/88 | 70% | 69/85 | 81% | ||
| Minor abnormality | 19/84 | 22% | 9/85 | 11% | ||
| Severe abnormality | 7/84 | 8% | 7/85 | 8% | ||
| Oxygen dependency at day 28, n (%) | 68 | 67% | 57 | 56% | 1.2 | 1.0 to 1.5 |
| Oxygen dependency at 36 weeks PMA, n (%) | 53 | 52% | 44 | 43% | 1.2 | 0.9 to 1.6 |
| At discharge: | ||||||
| Child exclusively breastfed | 11/100 | 11% | 12/100 | 12% | 1·2* | 0.5 to 2.8 |
| Child partially breastfed | 16/100 | 16% | 19/100 | 19% | 1·3* | 0.6 to 2.6 |
For categorical variables summary measures are number, %, RR and 95% CI.
For continuous variables summary measures are median (IQR), difference (95% CI).
The denominator is the entire population, unless otherwise stated.
↵* RR ratio estimated by multinomial regression.
GM-CSF, granulocyte-macrophage colony-stimulating factor.