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Neonatal MortalityPhase 3NCT00109616

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

A Phase 3 study testing Newborn skin cleansing with 0.25% chlorhexidine solution, Cleansing of umbilical cord with soap and water solution and Cleansing of umbilical cord with 4% chlorhexidine in people with Neonatal Mortality, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 minute to 10 daysHealthy volunteers can take part
Conditions the study is for
Neonatal Mortality
What is being tested?
Newborn skin cleansing with 0.25% chlorhexidine solution, Cleansing of umbilical cord with soap and water solution and Cleansing of umbilical cord with 4% chlorhexidine
How many people
17,000 participants
Where
2 sitesin 2 countries
Study dates
Oct 2002to Jan 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 minute to 10 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • All liveborn infants born in the study area

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Johns Hopkins Bloomberg School of Public Health

    Baltimore, Maryland, 21205-2103

Other trials in United States

Nepal1 site

  • Nepal Nutrition Intervention Project-Sarlahi

    Kathmandu and Sarlahi District

Other trials in Nepal

About this study

Official title: Newborn Antiseptic Washing and Neonatal Mortality-Nepal

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.

Read the 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.

Being tested
Newborn skin cleansing with 0.25% chlorhexidine solution, Cleansing of umbilical cord with soap and water solution, Cleansing of umbilical cord with 4% chlorhexidine
Keywords
neonatal mortality, chlorhexidine, newborn cleansing, umbilical cord care, community-based trial, prevention trial, omphalitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Newborn skin cleansing with 0.25% chlorhexidine solutionBehavioural

  • Cleansing of umbilical cord with soap and water solutionBehavioural

  • Cleansing of umbilical cord with 4% chlorhexidineBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. neonatal mortality

  2. umbilical cord infection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2005 (estimated)
  2. Study startOct 2002
  3. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
17,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00109616
Sponsor's protocol ID
R01HD044004
Other IDs
R01HD044004
Status last verified
Jan 2006
First submitted
29 Apr 2005
Last updated
1 May 2013
Results posted
No

Publications

  • 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.

    PubMed 14614373

  • 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.

    PubMed 16528107

  • 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.

    PubMed 16874163

  • 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.

    PubMed 18449064

  • 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.

    PubMed 15496868

  • 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.

    PubMed 15677372

  • 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.

    PubMed 16546539

  • 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.

    PubMed 16223755

  • 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.

    PubMed 16464960

  • 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.

    PubMed 17079556

  • 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.

    PubMed 17065275

  • 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.

    PubMed 16885929

  • 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.

    PubMed 17210728

  • 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.

    PubMed 18450881

  • 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.

    PubMed 18606930

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Newborn skin cleansing with 0.25% chlorhexidine solution, Cleansing of umbilical cord with soap and water solution and Cleansing of umbilical cord with 4% chlorhexidine in people with Neonatal Mortality, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

neonatal mortality. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00109616, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2013.

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