Table 1

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 IQRn or median% or IQRDifference or RR95% CI for difference or RR
Characteristics at trial entry
Male, n (%)4646%5049%0.90.7 to 1.2
Age at recruitment, h, median (IQR)4324–604628–63−4−10 to 1
Gestational age, weeks, median (IQR)2927–302927–300.1−0.3 to 0.7
Birthweight, g, median (IQR)839668 to 932788630–92819−34 to 70
Neutrophil count at trial entry, ×109/l, median (IQR)2.71.3––4.30−0.6 to 0.5
Neutropaenia (<1.1×109/l) at trial entry, n (%)16/9716%18/9719%0.90.5 to 1.6
Multiple pregnancies, n (%)2727%2222%1.20.8 to 2.0
Maternal antenatal steroids administered 4 h or more before delivery, n (%)80/8792%83/8894%1.00.9 to 1.1
Infants given surfactant within 4 h of birth, n (%)70/7989%76/8293%1.00.9 to 1.1
Cranial ultrasound findings at trial entry
 Minor abnormality21/10021%12/9712%
 Severe abnormality3/1003%3/973%
Short-term outcomes
Necrotising enterocolitis (confirmed at surgery or post mortem)22%44%0.50.1 to 2.7
Sepsis: culture positive to day 28 from trial entry2626%2222%1.20.7 to 2.0
Sepsis: culture positive and probable to day 282929%3433%0.90.6 to 1.3
Cranial ultrasound findings
 Minor abnormality19/8422%9/8511%
 Severe abnormality7/848%7/858%
Oxygen dependency at day 28, n (%)6867%5756%1.21.0 to 1.5
Oxygen dependency at 36 weeks PMA, n (%)5352%4443%1.20.9 to 1.6
At discharge:
 Child exclusively breastfed11/10011%12/10012%1·2*0.5 to 2.8
 Child partially breastfed16/10016%19/10019%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.