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Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal

This study has been completed.

Sponsor:

Collaborators:

United States Agency for International Development (USAID)

Bill and Melinda Gates Foundation

Information provided by:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ClinicalTrials.gov Identifier:

NCT00109616

First received: April 29, 2005

Last updated: April 30, 2013

Last verified: January 2006

History of Changes

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Study Status:	This study has been completed.
Estimated Study Completion Date:	January 2006
Estimated Primary Completion Date:	No date given

Publications:

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.

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. Epub 2005 Jan 26.

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.

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. Epub 2005 Oct 13.

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. Epub 2006 Feb 7.

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.

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. Epub 2006 Oct 25.

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. Epub 2006 Aug 2.

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. Epub 2007 Jan 8.

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.

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.

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.

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.

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.

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. Epub 2008 Jun 9.

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.

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.

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.

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.

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. Epub 2011 Jun 24.

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.

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. Epub 2011 Apr 1.

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.

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. PubMed PMID: 20603466.