Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Umbilical cord care in premature infants: the effect of two different cord-care regimens (salicylic sugar powder vs chlorhexidine) on cord separation time and other outcomes. Higher rate of cord-related adverse events in neonates with dry umbilical cord care compared to chlorhexidine powder. Results of a randomized controlled study to compare efficacy and safety of chlorhexidine powder versus dry care in umbilical cord care of the newborn. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Umbilical cord care: the effect of eight different cord-care regimens on cord separation time and other outcomes. [Umbilical colonization in normal newborns. A comparative study of 4 methods for umbilical antisepsis]. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Effect of antiseptic cord care on bacterial colonization in the newborn infant. Hydrophobic material in routine umbilical cord care and prevention of infections in newborn infants.
Omphalitis contributes to neonatal morbidity and mortality in developing countries. Umbilical cord cleansing with antiseptics might reduce infection and mortality risk, but has not been rigorously investigated.
                In our community-based, cluster-randomised trial, 413 communities in Sarlahi, Nepal, were randomly assigned to one of three cord-care regimens. 4934 infants were assigned to 4.0% chlorhexidine, 5107 to cleansing with soap and water, and 5082 to dry cord care. In intervention clusters, the newborn cord was cleansed in the home on days 1-4, 6, 8, and 10. In all clusters, the cord was examined for signs of infection (pus, redness, or swelling) on these visits and in follow-up visits on days 12, 14, 21, and 28. Incidence of omphalitis was defined under three sign-based algorithms, with increasing severity. Infant vital status was recorded for 28 completed days. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. Analysis was by intention-to-treat. This trial is registered with , number NCT00109616.
                Frequency of omphalitis by all three definitions was reduced significantly in the chlorhexidine group. Severe omphalitis in chlorhexidine clusters was reduced by 75% (incidence rate ratio 0.25, 95% CI 0.12-0.53; 13 infections/4839 neonatal periods) compared with dry cord-care clusters (52/4930). Neonatal mortality was 24% lower in the chlorhexidine group (relative risk 0.76 [95% CI 0.55-1.04]) than in the dry cord care group. In infants enrolled within the first 24 h, mortality was significantly reduced by 34% in the chlorhexidine group (0.66 [0.46-0.95]). Soap and water did not reduce infection or mortality risk.
                Recommendations for dry cord care should be reconsidered on the basis of these findings that early antisepsis with chlorhexidine of the umbilical cord reduces local cord infections and overall neonatal mortality. To evaluate the effect of 2 cord-care regimens (salicylic sugar powder vs chlorhexidine as a 4% detergent water solution) on cord separation time and other outcomes in preterm infants.
                A prospective, randomized, controlled trial was conducted on 244 preterm newborns with a gestational age of <34 weeks and a birth weight of <2500 g. All preterm newborns were enrolled, regardless of their health condition. We excluded from the study infants whose conditions during the first hours of life required the catheterization of umbilical vessels. We also excluded from the general statistical analysis all newborns who had their programmed cord-care regimen changed because of the presence or the suspicion of omphalitis. On arrival at our neonatal intensive care unit or neonatal special care unit, infants were bathed thoroughly with a soap solution (Saugella, Guieu, Italy), and the umbilical cord (UC) was treated with 1 of the 2 antiseptic products chosen for the study. The stump was then folded and covered with common sterile, dry gauze and kept in place by an elastic net. Until cord detachment and at every diaper change, the cord stump was cleaned with sterile water and treated with the same product initially used for first-time cord care. On the third day of life, we obtained an umbilical swab either from the base of the cord or from the umbilicus if the cord was already sloughed. Six weeks after birth, during hospitalization or during a follow-up visit if already discharged, all infants had a medical examination to check the umbilicus area. Cord separation time, changing of the programmed cord-care regimen, death, omphalitis, sepsis, cord bleeding, nurses' opinion on treatments efficacy, and UC colonization were measured.
                The cord separation time was significantly lower in infants who were treated with salicylic sugar powder (6 +/- 2 days) than in infants who were treated with chlorhexidine (9 +/- 2 days). The programmed cord-care regimen was changed in a significantly higher number of newborns in the chlorhexidine group (17) than in the salicylic sugar group (3). None of the newborns died, and we found only sporadic cases of sepsis (1 patient in each group) and omphalitis (1 patient in the chlorhexidine group). A significantly higher percentage of nurses were satisfied with the salicylic sugar powder treatment (98%) than with the chlorhexidine treatment (67%), notwithstanding a more frequent occurrence of slight cord scar bleeding in the salicylic sugar group (7.8%) than in the chlorhexidine group (4%). The rate of negative umbilical swabs was significantly higher in infants treated with salicylic sugar powder (73.1%) than with chlorhexidine (53%).
                In neonatal intensive care units and neonatal special care units of developed countries, salicylic sugar powder can be used effectively and safely for UC care of preterm infants. Best practice for umbilical cord care (UC) still remains controversial in developed countries with aseptic perinatal care. A bicenter randomized clinical trial was performed to evaluate the efficacy of chlorhexidine (CX) powder versus dry cord care (DC) for UC.
                All neonates of two neonatal care units were invited to take part in the study. Participants were randomized to either DC or UC with CX powder (0.1%). Primary study outcome was the cord separation time. Secondary outcomes were omphalitis, granuloma of the umbilical ground, adverse events and parents' treatment satisfaction. The outcome parameters were documented at a hospital-located study visit 10-14 days after birth.
                669 neonates were enrolled in the trial. 337 were randomized to receive CX powder for umbilical cord care, 332 to DC. Cord separation time was 7.0 +/- 2.5 days in CX-treated neonates and 7.8 +/- 2.9 days in DC (p < 0.001). There were 9 cases of omphalitis, 2 in the CX group, 7 in the DC group (p = 0.1). No difference in the occurrence of umbilical granuloma between the treatment regimens was detected. Neonates randomized to CX were less likely to have an adverse event (140 in 109 subjects vs. 205 in 149 subjects in the DC neonates; p = 0.001). Half of these adverse events were cord-related. Neonates randomized to DC had nearly twice as many cord-related adverse events as those with CX treatment (CX: 58 in 54 patients vs. DC: 110 in 97 patients; p < 0.001). Parents' treatment satisfaction was significantly higher in the neonates with CX cord care.
                Cord-related adverse events in neonatal umbilical cord care remain a clinical issue. Even in an aseptic birth context in a developed country, cord care with CX powder showed a reduction of cord-related adverse events.
                Copyright 2009 S. Karger AG, Basel. Umbilical cord infection (omphalitis) is a risk factor for neonatal sepsis and mortality in low-resource settings where home deliveries are common. We aimed to assess the effect of umbilical-cord cleansing with 4% chlorhexidine (CHX) solution, with or without handwashing with antiseptic soap, on the incidence of omphalitis and neonatal mortality.
                We did a two-by-two factorial, cluster-randomised trial in Dadu, a rural area of Sindh province, Pakistan. Clusters were defined as the population covered by a functional traditional birth attendant (TBA), and were randomly allocated to one of four groups (groups A to D) with a computer-generated random number sequence. Implementation and data collection teams were masked to allocation. Liveborn infants delivered by participating TBAs who received birth kits were eligible for enrolment in the study. One intervention comprised birth kits containing 4% CHX solution for application to the cord at birth by TBAs and once daily by family members for up to 14 days along with soap and educational messages promoting handwashing. One intervention was CHX solution only and another was handwashing only. Standard dry cord care was promoted in the control group. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. The trial is registered with ClinicalTrials.gov, number NCT00682006.
                187 clusters were randomly allocated to one of the four study groups. Of 9741 newborn babies delivered by participating TBAs, factorial analysis indicated a reduction in risk of omphalitis with CHX application (risk ratio [RR]=0·58, 95% CI 0·41-0·82; p=0·002) but no evidence of an effect of handwashing (RR=0·83, 0·61-1·13; p=0·24). We recorded strong evidence of a reduction in neonatal mortality in neonates who received CHX cleansing (RR=0·62, 95 % CI 0·45-0·85; p=0·003) but no evidence of an effect of handwashing promotion on neonatal mortality (RR=1·08, 0·79-1·48; p=0·62). We recorded no serious adverse events.
                Application of 4% CHX to the umbilical cord was effective in reducing the risk of omphalitis and neonatal mortality in rural Pakistan. Provision of CHX in birth kits might be a useful strategy for the prevention of neonatal mortality in high-mortality settings.
                The United States Agency for International Development.
                Copyright Â© 2012 Elsevier Ltd. All rights reserved. In this study we evaluate the effect of eight cord-care regimens on cord separation time and other secondary outcomes: omphalitis, sepsis, death, cord bleeding, compliance, satisfaction or dissatisfaction with regard to the type of treatment, umbilical cord colonization--in 1,535 healthy term infants. The eight cord-care regimens studied were: 70% alcohol, natural drying, salicylic sugar powder, triple dye, micronized green clay powder, colloid silver-benzyl-peroxide powder, neomycin-bacitracin powder, 1% basic fuchsine. None of the newborns developed sepsis or died and we found only sporadic cases of omphalitis. With regard to cord separation time the best results were obtained with salicylic sugar powder (5.6 +/- 2.3 days) and green clay powder (6.7 +/- 2.2 days). Both forms of treatment proved to be more effective (p < 0.05) than all the others. We found that salicylic sugar powder allows for early cord detachment resulting in excellent parent treatment compliance and reduction of their concern, notwithstanding higher percentages of cord bleeding. The rate of positive umbilical swabs was low and was significantly higher only than the results obtained with neomycin-bacitracin powder treatment. This study demonstrates that, in hospital nurseries of developed countries, salicylic sugar powder can be effectively and safely used for umbilical cord care of healthy term infants.
                Copyright 2002 S. Karger AG, Basel We report the results of a prospective study in which the effectiveness of 70% alcohol (A), mercurochrome (M), a solution of alcohol and mercurochrome (AM) and 1% chlorhexidine (C) as umbilical antiseptics was tested on 311 normal newborn infants. Similar results were obtained by using A, M, or AM; however, when C was used umbilical colonization was significantly reduced as compared to when the other three antiseptic agents were used. The umbilical cords that had been scrubbed with A, M or AM were detached by the 8th day after birth, whereas those treated with C took 14 days to fall off. The use of chlorhexidine resulted in a marked increase in pure cultures positive for Gram negative bacteria (Proteus spp. and Pseudomonas spp.) which was not the case with the other three antiseptics tested. Up to half of neonatal deaths in high mortality settings are due to infections, many of which can originate through the freshly cut umbilical cord stump. We aimed to assess the effectiveness of two cord-cleansing regimens with the promotion of dry cord care in the prevention of neonatal mortality.
                We did a community-based, parallel cluster-randomised trial in Sylhet, Bangladesh. We divided the study area into 133 clusters, which were randomly assigned to one of the two chlorhexidine cleansing regimens (single cleansing as soon as possible after birth; daily cleansing for 7 days after birth) or promotion of dry cord care. Randomisation was done by use of a computer-generated sequence, stratified by cluster-specific participation in a previous trial. All livebirths were eligible; those visited within 7 days by a local female village health worker trained to deliver the cord care intervention were enrolled. We did not mask study workers and participants to the study interventions. Our primary outcome was neonatal mortality (within 28 days of birth) per 1000 livebirths, which we analysed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00434408.
                Between June, 2007, and September, 2009, we enrolled 29 760 newborn babies (10 329, 9423, and 10 008 in the multiple-cleansing, single-cleansing, and dry cord care groups, respectively). Neonatal mortality was lower in the single-cleansing group (22·5 per 1000 livebirths) than it was in the dry cord care group (28·3 per 1000 livebirths; relative risk [RR] 0·80 [95% CI] 0·65-0·98). Neonatal mortality in the multiple-cleansing group (26·6 per 1000 livebirths) was not statistically significantly lower than it was in the dry cord care group (RR 0·94 [0·78-1·14]). Compared with the dry cord care group, we recorded a statistically significant reduction in the occurrence of severe cord infection (redness with pus) in the multiple-cleansing group (risk per 1000 livebirths=4·2 vs risk per 1000 livebirths=1·2; RR 0·35 [0·15-0·81]) but not in the single-cleansing group (risk per 1000 livebirths=3·3; RR 0·77 [0·40-1·48]).
                Chlorhexidine cleansing of a neonate's umbilical cord can save lives, but further studies are needed to establish the best frequency with which to deliver the intervention.
                United States Agency for International Development and Save the Children's Saving Newborn Lives program, through a grant from the Bill & Melinda Gates Foundation.
                Copyright Â© 2012 Elsevier Ltd. All rights reserved. A randomized controlled study was undertaken to compare the effectiveness of three umbilical cord treatment regimens in controlling neonatal bacterial colonization. The regimens studied included daily application of castile soap, triple dye and silver sulfadiazine. The triple dye and silver sulfadiazine regimens inhibited bacterial colonization. Staphylococcal colonization was inhibited most effectively by triple dye treatment. Group B streptococcal colonization was equally inhibited by triple dye and silver sulfadiazine. Silver sulfadiazine was more effective in controlling colonization with gram-negative microorganisms. In a prospective randomized study 2 different regimens for umbilical disinfection in newborn infants were tested: (i) a bandage of hydrophobic material (Sorbact; n = 1,213), and (ii) daily cleansing with 0.5% chlorhexidine in 70% ethanol (n = 1,228). Infections were registered in the nursery as well as after discharge until 6 weeks of age, and bacterial cultures taken from infected areas. A total of 410 infections were registered in 377 (15.4%) of the 2,441 infants. Total infection rates of 16.3 and 14.6% were found in the hydrophobic material group and the chlorhexidine-ethanol group respectively (p greater than 0.05). No differences were found between the groups in infection rates in the nursery (8.9 vs. 8.7%), after discharge (7.4 vs. 5.9%), or in rates of different types of infections (conjunctivitis, pyoderma, paronychia, omphalitis) (p greater than 0.05). 536 strains were isolated. 498 (92.9%) were gram-positive, 45 (8.4%) gram-negative, and 7 (1.3%) candida strains. 229 (55.9%) were Staphylococcus aureus strains. No differences were found between the two groups concerning distribution of the different strains isolated. Separation of the umbilical cord occurred significantly later in the hydrophobic material group than in the chlorhexidine-ethanol group (6.2 +/- 2.2 vs. 5.8 +/- 2.1 days; p less than 0.05). Hydrophobic material does not prevent infections more effectively compared to 0.5% chlorhexidine in 70% alcohol.
There is significant evidence to suggest that topical application of chlorhexidine to umbilical cord reduces neonatal mortality and omphalitis in community and primary care settings in developing countries. It may increase cord separation time however, there is no evidence that it increases risk of subsequent morbidity or infection.
There is insufficient evidence to support the application of an antiseptic to umbilical cord in hospital settings compared with dry cord care in developed countries.