Methylated spirit versus 4% chlorhexidine gel in neonatal umbilical cord infection: A short report of a randomized, openlabelled, parallel-group trial

Abstract

Background : Neonatal sepsis is a known leading cause of neonatal morbidity and mortality. Aim : To compare the efficacies of 96% methylated spirit and 4% chlorhexidine (CHX) gel in the treatment of umbilical stump of neonates. Method : This was a randomized, open labelled, parallel group trial of CHX gel and Methylated spirit for neonatal umbilical cord care in Jos, between 2/6/17 and 16/7/17. Inclusion criteria were term, newly born 0 to 6 hours old, with no known risk for sepsis and written informed parental consent. Eligible subjects were randomized to receive methylated spirit or 4% CHX gel. Outcome measures were cord separation time, omphalitis, neonatal sepsis and neonatal mortality by day 28. Results : A total sample of 51 of 58 met enrolment criteria. Thirtytwo (62.7%) where delivered in JUTH, 33(64.7%) were males with a mean birth weight of 3.7kg (CI 3.04 – 3.30). Mean cord separation times were 7.96 ± 4.07)days in the methylated spirit group vs 6.43 ± 3.13days in the CHX comparator group, (p=0.078). Omphalitis was0% vs2(8.3%) and NNS 2 (7.4%)vs2(8.3%) in methylated spirit and CHX treatment groups respectively. There was 1(3.7%) mortality in the methylated spirit treatment group. Conclusion : Methylated spirit and 4% CHX gel have comparable umbilical stump treatment efficacy. Methylated spirit may be a safe alternative in clinical settings where topical 4% CHX gel is unavailable or unsafe. Key words : Methylated spirit, 4% Chlorhexidine gel, mortality, Cord separation time, Neonatal sepsis, Omphalitis