Incidence and Risk Factors for Omphalitis among Neonates in the control arm of the babygel trial in eastern Uganda: A mixed methods study

Abstract

ABSTRACT Background: Omphalitis is bacterial infection of the umbilicus and/or surrounding tissues, occurring primarily in the neonatal period. Whereas it is known to be a major route of localized and often systemic infection, studies describing incidence and risk factors remain scanty, especially in resource limited settings where the condition is thought to be common. The clinical picture and burden of disease due to omphalitis therefore remains incomplete. We assessed the incidence and risk factors for omphalitis among neonates born to women who received a birth kit containing chlorhexidine gel for umbilical cord care after birth in the control arm of the BabyGel trial. We also explored umbilical cord care practices in this cohort. Methods: We conducted a sequential explanatory mixed methods study that employed a retrospective cohort study and a qualitative study borrowing upon a phenomenological strategy of inquiry. The study was nested in the control arm of the BabyGel trial. First, we conducted the quantitative study, where we included a total of 2052 mother baby pairs. Omphalitis was defined as presence of pus on the umbilical cord stump in the first 28 days of life as observed by a research midwife. The research midwives visited mothers at home on day 1,7, and 28. All participants in the BabyGel study were given chlorhexidine and the study midwives helped to administer it if the birth attendant had not yet done so. Data were analysed using Stata version 17.0 (StataCorp LLC, College Station, Texas, USA). Analyses were conducted using Cox proportional hazard regression models to estimate hazard ratios (HR) of selected exposures and time to omphalitis. Thereafter, we conducted a qualitative study to explore umbilical cord care practices among women that were purposively sampled. This was used to explain findings of the quantitative study. We conducted four focus group discussions (FGD) and sixteen in-depth interviews (IDI). Data were analysed using thematic analysis with the help of ATLAS.ti 9 software. We combined the results from the quantitative and qualitative phases in the discussion. Results: Of the 2052 participant that were included in our study, more than half (51.1%) were females. The incidence of omphalitis was 3.0% (62/2052, 95% confidence interval [CI]: 1.9, 4.4). The incidence rate of omphalitis was 1.6 cases per 1000 person days (95% CI:1.1, 2.3). Children born at home were twice as likely to develop omphalitis compared to children that were born in the health facility (Adjusted Hazards Ratio 1.98, 95% CI:1.01, 3.92). Most mothers used the chlorhexidine (FGD 23/26, IDI 14/16) provided for umbilical cord care and the cord was tied and cut using the sterile thread and surgical blade that were included in their birth kit. Participants appreciated chlorhexidine for umbilical cord care and linked it to quick drying of the cord and a reduction in the umbilical cord associated foul smell. However, they noted that use of chlorhexidine resulted in a prolonged cord separation time and some mothers resorted to applying other substances to hasten cord separation. Some mothers that gave birth from home did not use chlorhexidine but instead used other unhygienic substances for cord care. Conclusion: The incidence of omphalitis observed in this community was 3%. Home birth was associated with omphalitis. Poor cord care practices such as application of unhygienic substances to the cord were mainly practiced by mothers that gave birth at home. Distribution and application of chlorhexidine for umbilical cord care by community health workers should be considered by policy makers.