Abstract
OBJECTIVE: To compare the effects of human breast milk with those of chlorhexidine and the dry method on umbilical cord separation in Ethiopia. METHODS: This open-label 3-arm nonrandomized pilot clinical trial was conducted among 45 neonates (15 in each arm) with more than 630 home visits. After a standard cord cut, human breast milk, chlorhexidine, or nothing was applied once per day for 7 days. The primary outcome was the duration of cord separation, while the secondary outcomes were umbilical cord infection, neonatal fever, jaundice, feeding and breathing difficulty, and persistent crying. RESULTS: There were statistically significant differences in the time-to-cord separation between the human breast milk group and the chlorhexidine (P < 0.001) and dry alone (P = 0.038) groups. Compared to those of chlorhexidine, the rates of cord separation among human breast milk and the dry-alone group were 16.02, with 95% confidence intervals (3.81, 37.43; P < 0.001) and 3.15 (0.99, 10.00; P = 0.052), respectively. One (6.7%) cord site infection was observed in the dry-alone groups only. CONCLUSION: This community-label study indicated that human breast milk application significantly shortened the length of umbilical cord separation time compared to chlorhexidine and dry methods. A large-scale randomized controlled trial is needed to confirm these results. REGISTRATION: PACTR202310902873290; https://pactr.samrc.ac.za.