Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India: a randomized controlled study

Sushma Nangia, Usha Dhingra, Pratibha Dhingra, Arup Dutta, Venugopal P Menon, Robert E Black, Sunil Sazawal, Sushma Nangia, Usha Dhingra, Pratibha Dhingra, Arup Dutta, Venugopal P Menon, Robert E Black, Sunil Sazawal

Abstract

Background: Infections are the single most important cause of neonatal mortality in developing countries. Results from trials in Asia evaluating the effect of chlorhexidine on neonatal mortality have been encouraging but limited data are available on the impact of cord cleansing on bacterial colonization. Further, no data from facility deliveries and impact with time is available. This pilot study was aimed to evaluate the impact of 4 % commercially prepared chlorhexidine on cord colonization and density of colonization among newborns in India.

Methods: Three hundred twenty-six newborns (hospital-247; community-79) were enrolled within 24 h of birth and randomly assigned to one of three groups: chlorhexidine, placebo or dry cord care. Umbilical swabs were collected at baseline, 2- and 48- hours after intervention application.

Results: At baseline, growth positivity (any bacterial growth) was 20 % (50 of 247 swabs) and 81 % (64 of 79 swabs) among hospital and community born neonates, respectively. In both settings, chlorhexidine compared to placebo and dry cord care, reduced colonization following 2- and 48-hour post application. Chlorhexidine significantly reduced 48-hour post application colony counts in comparison to placebo [Hospital: mean difference = -1.01; 95 % CI: -1.72, -0.30 Community: mean difference = -1.76; 95 % CI: -2.60, -0.93] and dry cord care [Hospital: mean difference = -1.16; 95 % CI: -1.93, -0.39 Community: mean difference = -2.23; 95 % CI: -3.18, -1.29]. Differences were similar for gram-positive and gram-negative bacteria.

Conclusions: Cord cleansing with 4 % chlorhexidine soon after birth reduced colonization as well as density of colonization significantly; however this pilot study does not address the impact of chlorhexidine on mortality. The control preparation neither increased or decreased colonization.

Clinical trial registration: clinicaltrials.gov: NCT01528852, Registered February 7, 2012.

Keywords: Bacterial count; Chlorhexidine; Colonization; Cord cleaning; India; Neonates; Newborns; Umbilical cord.

Figures

Fig. 1
Fig. 1
Study participants flow diagram

References

    1. Lawn JE, Kinney MV, Black RE, Pitt C, Cousens S, Kerber K, Corbett E, et al. Health Policy Plan. 2012;27(Suppl 3):iii6–iii28. doi: 10.1093/heapol/czs053.
    1. Oestergaard MZ, Inoue M, Yoshida S, Mahanani WR, Gore FM, Cousens S, et al. Neonatal mortality levels for 193 countries in 2009 with trends since 1990: a systemic analysis of progress, projections and priorities. PLoS Med. 2011;8:e1001080. doi: 10.1371/journal.pmed.1001080.
    1. UNICEF, WHO, The World Bank, the United Nations Population Division . Levels and Trends in Child Mortality. Geneva: UNICEF; 2011.
    1. Lawn JE, Cousens S, Zupan J, Lancet Neonatal Survival Steering Team 4 million Neonatal Deaths: When? Where? Why? Lancet. 2005;365:891–900. doi: 10.1016/S0140-6736(05)71048-5.
    1. Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, et al. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012;379:2151–2161. doi: 10.1016/S0140-6736(12)60560-1.
    1. Thaver D, Zaidi AKM. Burden of neonatal infections in developing countries: a review of evidence from community-based studies. Pediatr Infect Dis J. 2009;28(Suppl 1):S3–S9. doi: 10.1097/INF.0b013e3181958755.
    1. Jellard J. Umbilical cord as reservoir of infection in a maternity hospital. Br Med J. 1957;1:925–928. doi: 10.1136/bmj.1.5024.925.
    1. Remington JS. Neonatal infection. In: Remington JS, Klein JO, editors. Infectious Diseases of the Fetus and Newborn Infant. 5. London: W.B. Saunders; 2001. pp. 149–150.
    1. Goldenberg RL, McClure EM, Saleem S, Rouse D, Vermund S. Use of vaginally administered chlorhexidine during labor to improve pregnancy outcomes. Obstet Gynecol. 2006;107:1139–1146. doi: 10.1097/01.AOG.0000215000.65665.dd.
    1. World Health Organisation . Care of the Umbilical Cord: A review of the evidence. Geneva: World Health Organisation; 1998.
    1. Mullany LC, Darmstadt GL, Katz J, Khatry SK, LeClerq SC, Adhikari RK, et al. Development of clinical sign based algorithms for community based assessment of omphalitis. Arch Dis Child Fetal Neonatal Ed. 2006;91:F99–F104. doi: 10.1136/adc.2005.080093.
    1. Mullany LC, Darmstadt GL, Katz J, Khatry SK, Leclerq SC, Adhikari RK, et al. Risk of mortality subsequent to umbilical cord infection among newborns of southern Nepal: cord infection and mortality. Pediatr Infect Dis J. 2009;28:17–20. doi: 10.1097/INF.0b013e318181fb4c.
    1. Mullany LC, El Arifeen S, Winch PJ, Shah R, Mannan I, Rahman SM, et al. Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial. BMC Pediatr. 2009;9:67. doi: 10.1186/1471-2431-9-67.
    1. Zupan J, Garner P, Omari AA. Topical umbilical cord care at birth. Cochrane Database Syst Rev. 2004;3:CD001057.
    1. World Health Organization . Review of the available evidence on 4% chlorhexidine solution for umbilical cord care. Second Meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential Medicines. Geneva: WHO; 2008.
    1. Mullany LC, Darmstadt GL, Khatry SK, LeClerq SC, Katz J, Tielsch JM. Impact of umbilical cord cleansing with 4.0% chlorhexidine on time to cord separation among newborns in southern Nepal: a cluster-randomized, community-based trial. Pediatrics. 2006;118:1864–1871. doi: 10.1542/peds.2006-1091.
    1. Larson EL and 1992, 1993, and 1994 APIC Guidelines Committee 18. APIC guideline for handwashing and hand antisepsis in health care settings. Source School of Nursing, Georgetown University, Washington, D.C., USA. [ 1995]
    1. O’Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, et al. Guidelines for the prevention of intravascular catheter related infections. The hospital Infection Control Practices Advisory committee, Center for Disease Control and Prevention, U.S. Pediatrics. 2002;110:e51. doi: 10.1542/peds.110.5.e51.
    1. McClure EM, Goldenberg RL, Brandes N, Darmstadt GL, Wright LL, CHX Working Group et al. The use of chlorhexidine to reduce maternal and neonatal mortality and morbidity in low-resource settings. Int J Gynaecol Obstet. 2007;97:89–94. doi: 10.1016/j.ijgo.2007.01.014.
    1. Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, et al. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet. 2006;367:910–918. doi: 10.1016/S0140-6736(06)68381-5.
    1. Sinha A, Sazawal S, Pradhan A, Ramji S, Opiyo N. Chlorhexidine skin or cord care for prevention of mortality and infections in neonates. Cochrane Database Syst Rev. 2015;3:CD007835.
    1. Seeberg S, Brinkhoff B, John E, Kjellmer I. Prevention and control of neonatal pyoderma with chlorhexidine. Acta Paediatr Scand. 1984;73:498–504. doi: 10.1111/j.1651-2227.1984.tb09961.x.
    1. Parashar UD, Bennett JV, Boring JR, Hlady WG. Topical antimicrobials applied to the umbilical cord stump: a new intervention against neonatal tetanus. Int J Epidemiol. 1998;27:904–908. doi: 10.1093/ije/27.5.904.
    1. Mullany LC, Darmstadt GL, Katz J, Khatry SK, LeClerq SC, Adhikari RK, et al. Risk factors for umbilicalCord infection among newborns of southern Nepal. Am J Epidemiol. 2007;165:203–211. doi: 10.1093/aje/kwj356.
    1. Mullany LC, Saha SK, Shah R, Islam MS, Rahman M, Islam M, Talukder RR, et al. Impact of 4.0% chlorhexidine cord cleansing on the bacteriologic profile of the newborn umbilical stump in rural Sylhet District, Bangladesh: a community-based, cluster-randomized trial. Pediatr Infect Dis J. 2012;31:444–450. doi: 10.1097/INF.0b013e3182468ff0.
    1. Hodgins S, Thapa K, Khanal L, Aryal S, Suvedi BK, Baidya U, et al. Chlorhexidine gel versus aqueous for preventive use on umbilical stump: a randomized noninferiority trial. Pediatr Infect Dis J. 2010;29:999–1003.
    1. James L, Hoppe-Bauer JE. Processing and interpretation of lower respiratory tract specimen. In: Isenberg HD, editor. Clinical microbiology procedures handbook. Washington: American Society for Microbiology; 1992. pp. 1.15.1–1.15.8.
    1. Goldenberg RL, McClure EM, Saleem S. A review of studies with chlorhexidine applied directly to the umbilical cord. Am J Perinatol. 2013;30:699–701.
    1. Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, et al. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012;379:1022–1028. doi: 10.1016/S0140-6736(11)61848-5.
    1. Belfrage E, Enocksson E, Kalin M, Marland M. Comparative efficiency of chlorhexidine and ethanol in umbilical cord care. Scand J Infect Dis. 1985;17:413–420.
    1. Athanassiadis B, Abbott PV, Walsh LJ. The use of calcium hydroxide, antibiotics and biocides as antimicrobial medicaments in endodontics. Aust Dent J. 2007;52:S64–S82. doi: 10.1111/j.1834-7819.2007.tb00527.x.
    1. Gomes BP, Souza SF, Ferraz CC, Teixeira FB, Zaia AA, Valdrighi L, et al. Effectiveness of 2% chlorhexidine gel and calcium hydroxide against Enterococcus faecalis in bovine root dentine in vitro. Int Endod J. 2003;36:267–275. doi: 10.1046/j.1365-2591.2003.00634.x.
    1. Gomes BP, Sato E, Ferraz CC, Teixeira FB, Zaia AA, Souza- Filho FJ. Evaluation of time required for recontamination of coronally sealed canals medicated with calcium hydroxide and chlorhexidine. Int Endod J. 2003;36:604–609. doi: 10.1046/j.1365-2591.2003.00694.x.
    1. Mohammadi Z, Abbott PV. The properties and applications of chlorhexidine in endodontics. Int Endod J. 2009;42:288–302. doi: 10.1111/j.1365-2591.2008.01540.x.
    1. Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L, et al. Evidence based cost effective interventions: how many newborn babies can we save? Lancet. 2005;365:977–988. doi: 10.1016/S0140-6736(05)71088-6.
    1. Mullany LC, Khatry SK, Sherchand JB, LeClerq SC, Darmstadt GL, Katz J, et al. A randomized controlled trial of the impact of chlorhexidine skin cleansing on bacterial colonization of hospital-born infants in Nepal. Pediatr Infect Dis J. 2008;27:505–511. doi: 10.1097/INF.0b013e31816791a2.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다