Clinical trial NCT00109616: Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal
Official title: Newborn Antiseptic Washing and Neonatal Mortality-Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neonatal Mortality
Keywords: neonatal mortality
chlorhexidine
newborn cleansing
umbilical cord care
community-based trial
prevention trial
omphalitis
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: United States Agency for International Development (USAID)
name: Bill and Melinda Gates Foundation
First posted: 2005-05-02
Enrollment: 17000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver babies at home without a skilled birth attendant.

The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and water or an antiseptic solution for the first few days of life can reduce umbilical cord infections.

Detailed description: While significant progress has been made in reducing preschool child mortality in developing countries over the past 20 years, much less progress has been made in reducing neonatal mortality and morbidity. Neonatal mortality rates are high in Nepal; a significant proportion of which are due to sepsis. In addition, the vast majority of women deliver babies at home without a skilled birth attendant and early neonatal care is routinely used in rural areas. Previous hospital-based research in Malawi suggested that newborn cleansing with a dilute chlorhexidine solution could reduce early infant mortality. This project evaluates the use of a simple intervention at the community level and the impact on neonatal mortality.

Comparisons: Two nested community-based randomized trials are being conducted. The first compares the neonatal mortality rates between newborn infants randomized to receive a whole body skin cleansing soon after birth with baby wipes impregnated with 0.25% chlorhexidine compared with newborns cleaned with baby wipes with a placebo solution. The second trial compares the rates of umbilical cord infections among children assigned to three groups:

* education of the mother on clean cord care alone;
* education of the mother plus routine washing of the cord and stump with soap and water solution for the first 10 days of life; -OR-
* education of the mother plus routine washing of the cord and stump with a 4% chlorhexidine solution.

Enrolled infants are visited on a regular basis during the first month of life to record vital status and grade the cord for signs of infection.

Eligibility criteria: Inclusion Criteria:

* All liveborn infants born in the study area

Exclusion Criteria:

* Newborn infants who died prior to study staff arriving to conduct the interventions

Primary outcomes:
measure: neonatal mortality
measure: umbilical cord infection
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
city: Kathmandu and Sarlahi District
country: Nepal
facility: Nepal Nutrition Intervention Project-Sarlahi
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: James M Tieslch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mullany LC, Darmstadt GL, Tielsch JM. Role of antimicrobial applications to the umbilical cord in neonates to prevent bacterial colonization and infection: a review of the evidence. Pediatr Infect Dis J. 2003 Nov;22(11):996-1002. doi: 10.1097/01.inf.0000095429.97172.48.
citation: Mullany LC, Darmstadt GL, Khatry SK, LeClerq SC, Tielsch JM. Safety of neonatal skin cleansing in rural Nepal. Indian Pediatr. 2006 Feb;43(2):117-24.
citation: Mullany LC, Darmstadt GL, Tielsch JM. Safety and impact of chlorhexidine antisepsis interventions for improving neonatal health in developing countries. Pediatr Infect Dis J. 2006 Aug;25(8):665-75. doi: 10.1097/01.inf.0000223489.02791.70.
citation: Mullany LC, Khatry SK, Sherchand JB, LeClerq SC, Darmstadt GL, Katz J, Gauchan P, Adhikari RK, Rana A, Tielsch JM. 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 Jun;27(6):505-11. doi: 10.1097/INF.0b013e31816791a2.
citation: Mullany LC, Darmstadt GL, Katz J, Khatry SK, Tielsch JM. Effect of instrument precision on estimation of low birth weight prevalence. J Perinatol. 2005 Jan;25(1):11-3. doi: 10.1038/sj.jp.7211209.
citation: Mullany LC, Darmstadt GL, Khatry SK, Tielsch JM. Traditional massage of newborns in Nepal: implications for trials of improved practice. J Trop Pediatr. 2005 Apr;51(2):82-6. doi: 10.1093/tropej/fmh083. Epub 2005 Jan 26.
citation: Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. 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 Mar 18;367(9514):910-8. doi: 10.1016/S0140-6736(06)68381-5.
citation: Mullany LC, Darmstadt GL, Katz J, Khatry SK, LeClerq SC, Adhikari RK, Tielsch JM. Development of clinical sign based algorithms for community based assessment of omphalitis. Arch Dis Child Fetal Neonatal Ed. 2006 Mar;91(2):F99-104. doi: 10.1136/adc.2005.080093. Epub 2005 Oct 13.
citation: Mullany LC, Darmstadt GL, Coffey P, Khatry SK, LeClerq SC, Tielsch JM. A low cost, colour coded, hand held spring scale accurately categorises birth weight in low resource settings. Arch Dis Child. 2006 May;91(5):410-3. doi: 10.1136/adc.2005.088781. Epub 2006 Feb 7.
citation: 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 Nov;118(5):1864-71. doi: 10.1542/peds.2006-1091.
citation: Mullany LC, Darmstadt GL, Katz J, Khatry SK, LeClerq SC, Adhikari RK, Tielsch JM. Risk factors for umbilical cord infection among newborns of southern Nepal. Am J Epidemiol. 2007 Jan 15;165(2):203-11. doi: 10.1093/aje/kwj356. Epub 2006 Oct 25.
citation: Mullany LC, Darmstadt GL, Khatry SK, Leclerq SC, Tielsch JM. Relationship between the surrogate anthropometric measures, foot length and chest circumference and birth weight among newborns of Sarlahi, Nepal. Eur J Clin Nutr. 2007 Jan;61(1):40-6. doi: 10.1038/sj.ejcn.1602504. Epub 2006 Aug 2.
citation: Tielsch JM, Darmstadt GL, Mullany LC, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R. Impact of newborn skin-cleansing with chlorhexidine on neonatal mortality in southern Nepal: a community-based, cluster-randomized trial. Pediatrics. 2007 Feb;119(2):e330-40. doi: 10.1542/peds.2006-1192. Epub 2007 Jan 8.
citation: Lee AC, Mullany LC, Tielsch JM, Katz J, Khatry SK, LeClerq SC, Adhikari RK, Shrestha SR, Darmstadt GL. Risk factors for neonatal mortality due to birth asphyxia in southern Nepal: a prospective, community-based cohort study. Pediatrics. 2008 May;121(5):e1381-90. doi: 10.1542/peds.2007-1966.
citation: Rhee V, Mullany LC, Khatry SK, Katz J, LeClerq SC, Darmstadt GL, Tielsch JM. Maternal and birth attendant hand washing and neonatal mortality in southern Nepal. Arch Pediatr Adolesc Med. 2008 Jul;162(7):603-8. doi: 10.1001/archpedi.162.7.603.
citation: Mullany LC, Katz J, Li YM, Khatry SK, LeClerq SC, Darmstadt GL, Tielsch JM. Breast-feeding patterns, time to initiation, and mortality risk among newborns in southern Nepal. J Nutr. 2008 Mar;138(3):599-603. doi: 10.1093/jn/138.3.599.
citation: Lee AC, Mullany LC, Tielsch JM, Katz J, Khatry SK, LeClerq SC, Adhikari RK, Shrestha SR, Darmstadt GL. Verbal autopsy methods to ascertain birth asphyxia deaths in a community-based setting in southern Nepal. Pediatrics. 2008 May;121(5):e1372-80. doi: 10.1542/peds.2007-2644.
citation: Sharma V, Katz J, Mullany LC, Khatry SK, LeClerq SC, Shrestha SR, Darmstadt GL, Tielsch JM. Young maternal age and the risk of neonatal mortality in rural Nepal. Arch Pediatr Adolesc Med. 2008 Sep;162(9):828-35. doi: 10.1001/archpedi.162.9.828.
citation: Rosenberg RE, Ahmed S, Saha SK, Ahmed AS, Chowdhury MA, Law PA, Choi Y, Mullany LC, Tielsch JM, Katz J, Black RE, Santosham M, Darmstadt GL. Simplified age-weight mortality risk classification for very low birth weight infants in low-resource settings. J Pediatr. 2008 Oct;153(4):519-24. doi: 10.1016/j.jpeds.2008.04.051. Epub 2008 Jun 9.
citation: Thatte N, Mullany LC, Khatry SK, Katz J, Tielsch JM, Darmstadt GL. Traditional birth attendants in rural Nepal: knowledge, attitudes and practices about maternal and newborn health. Glob Public Health. 2009;4(6):600-17. doi: 10.1080/17441690802472406.
citation: Mullany LC, Darmstadt GL, Katz J, Khatry SK, Leclerq SC, Adhikari RK, Tielsch JM. Risk of mortality subsequent to umbilical cord infection among newborns of southern Nepal: cord infection and mortality. Pediatr Infect Dis J. 2009 Jan;28(1):17-20. doi: 10.1097/INF.0b013e318181fb4c.
citation: Falle TY, Mullany LC, Thatte N, Khatry SK, LeClerq SC, Darmstadt GL, Katz J, Tielsch JM. Potential role of traditional birth attendants in neonatal healthcare in rural southern Nepal. J Health Popul Nutr. 2009 Feb;27(1):53-61. doi: 10.3329/jhpn.v27i1.3317.
citation: Mullany LC, Katz J, Khatry SK, Leclerq SC, Darmstadt GL, Tielsch JM. Incidence and seasonality of hypothermia among newborns in southern Nepal. Arch Pediatr Adolesc Med. 2010 Jan;164(1):71-7. doi: 10.1001/archpediatrics.2009.239.
citation: Karas DJ, Mullany LC, Katz J, Khatry SK, LeClerq SC, Darmstadt GL, Tielsch JM. Home care practices for newborns in rural southern Nepal during the first 2 weeks of life. J Trop Pediatr. 2012 Jun;58(3):200-7. doi: 10.1093/tropej/fmr057. Epub 2011 Jun 24.
citation: Lee AC, Mullany LC, Tielsch JM, Katz J, Khatry SK, LeClerq SC, Adhikari RK, Darmstadt GL. Incidence of and risk factors for neonatal respiratory depression and encephalopathy in rural Sarlahi, Nepal. Pediatrics. 2011 Oct;128(4):e915-24. doi: 10.1542/peds.2010-3590. Epub 2011 Sep 26.
citation: Lee AC, Mullany LC, Tielsch JM, Katz J, Khatry SK, Leclerq SC, Adhikari RK, Darmstadt GL. Community-based stillbirth rates and risk factors in rural Sarlahi, Nepal. Int J Gynaecol Obstet. 2011 Jun;113(3):199-204. doi: 10.1016/j.ijgo.2010.12.015. Epub 2011 Apr 1.
citation: Mullany LC, Katz J, Khatry SK, LeClerq SC, Darmstadt GL, Tielsch JM. Neonatal hypothermia and associated risk factors among newborns of southern Nepal. BMC Med. 2010 Jul 8;8:43. doi: 10.1186/1741-7015-8-43.
citation: Mullany LC, Katz J, Khatry SK, LeClerq SC, Darmstadt GL, Tielsch JM. Risk of mortality associated with neonatal hypothermia in southern Nepal. Arch Pediatr Adolesc Med. 2010 Jul;164(7):650-6. doi: 10.1001/archpediatrics.2010.103.
citation: Subedi S, Katz J, Erchick DJ, Verhulst A, Khatry SK, Mullany LC, Tielsch JM, LeClerq SC, Christian P, West KP, Guillot M. Does higher early neonatal mortality in boys reverse over the neonatal period? A pooled analysis from three trials of Nepal. BMJ Open. 2022 May 19;12(5):e056112. doi: 10.1136/bmjopen-2021-056112.
citation: Rosenstock S, Katz J, Mullany LC, Khatry SK, LeClerq SC, Darmstadt GL, Tielsch JM. Sex differences in neonatal mortality in Sarlahi, Nepal: the role of biology and environment. J Epidemiol Community Health. 2013 Dec 1;67(12):986-91. doi: 10.1136/jech-2013-202646. Epub 2013 Jul 19.