Table 3

Secondary outcomes

CHX–IA
(n=148)
PI
(n=156)
p Value
Skin damage from IMP*3 (2)2 (1.3)0.677
Raised TSH on screening*0 (0)12 (7.7)<0.001
Raised TSH in serum*0 (0)10 (6.4)0.002
Treatment with thyroxine*0 (0)8 (5.1)0.003
Confirmed LOS (non-CR-BSI)*17 (11.5)26 (16.7)0.249
Suspected sepsis*13 (8.7)12 (7.7)0.835
Courses of antibiotics per patient‡2 (2, 4)3 (2, 4)0.588
Total days of antibiotics per patient‡5 (2, 12)5 (2, 12)0.786
No of blood cultures performed per patient‡3 (2, 5)3 (2, 5)0.319
Any respiratory support on day 28*77 (52)89 (57)0.42
Oxygen at 36 weeks CGA*27 (18.2)47 (30.1)0.017
NEC≥Bell stage 2*14 (9.5)15 (9.6)1.0
Any ROP*31 (21.1)31 (19.8)0.845
CRUSS IVH III/IV or PVL*16 (10.8)22 (14.1)0.488
Death prior to hospital discharge*15 (10.1)18 (11.5)0.716
Duration of hospital stay (days)‡59 (49, 85)67 (46, 90)0.199
  • Data are * n (%), median (IQR).

  • CGA, corrected gestational age; CHX–IA, 2% chlorhexidine–70% isopropyl alcohol; CRUSS, cranial ultrasound scan; IMP, investigational medicinal product; IVH, intraventricular haemorrhage; LOS, late-onset sepsis; NEC, nectrotising enterocolitis; PI, 10% aqueous povidone-iodine; PVL, periventricular leukomalacia; ROP, retinopathy of prematurity; TSH, thyroid-stimulating hormone.