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.