Table 2. Characteristics of the infants with outcome known and not known according to treatment assignment*.
Variable | Outcome Known | Outcome not known | Comparison | ||||
---|---|---|---|---|---|---|---|
Dex | Placebo | P1 | Dex | Placebo | P1 | P-value2 | |
n = 102 | n = 92 | n = 9 | n = 17 | ||||
Baseline variables | |||||||
Birth weight – g. | 733±132 | 724±129 | 0.66 | 756±128 | 795±145 | 0.50 | 0.06 |
Gestational age – wk. | 25±1.75 | 25±1.64 | 0.95 | 25±1 | 26±1 | 0.63 | 0.30 |
Male – no. (%) | 54(53) | 49(53) | 0.97 | 5(56) | 6(35) | 0.42 | 0.30 |
Inborn – no. (%) | 95(93) | 87(95) | 0.68 | 9(100) | 16(94) | 1.00 | 1.00 |
SGA – no. (%) | 12(12) | 13(14) | 0.62 | 1(11) | 0(0) | 0.35 | 0.33 |
Antenatal steroids - no. (%) | 75(74) | 70(76) | 0.68 | 7(78) | 12(71) | 1.00 | 0.81 |
Neonatal Outcomes** | |||||||
BPD – no./total no. (%) | 39/78(50) | 41/66(62) | 0.15 | 5(56) | 12(71) | 0.67 | 0.35 |
Clinical steroid use – no. (%) | 33(32) | 45(49) | 0.02 | 5(56) | 11(65) | 0.69 | 0.04 |
IVH | |||||||
Any – no./total no. (%) | 42/101(42) | 28(30) | 0.11 | 2(22) | 9(53) | 0.22 | 0.55 |
Severe (III or IV) – no./total no. (%) | 21/101(21) | 17(19) | 0.69 | 1(11) | 5(29) | 0.38 | 0.69 |
PVL – no./total no. (%) | 6/101(6) | 6(7) | 1.00 | 0(0) | 1(6) | 1.00 | 1.00 |
GI perforations – no. (%) | 14(14) | 7(8) | 0.17 | 2(22) | 1(6) | 0.27 | 1.00 |
ROP (all grades) – no./total no.(%) | 67/80(84) | 53/64(83) | 0.88 | 6/8(75) | 13/16(81) | 1.00 | 0.57 |
Plus-minus values are means ± SD.
Total number refers to the number of infants assessed for the outcome if different from the number in that group.
Dex = dexamethasone; SGA = small for gestational age; CLD = chronic lung disease, defined as oxygen supplementation at 36 weeks postmenstrual age; IVH = intraventricular hemorrhage; PVL = periventricular leukomalacia; GI perforation = spontaneous gastrointestinal perforation within first 14 days; ROP = retinopathy of prematurity.
Comparison between dexamethasone and placebo groups with either known or unknown outcome.
Comparison between infants with known and unknown outcomes.