CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 77,535 enrolled
Drug / intervention
Chlorhexidine gluconate (4%) +1 moredrug
Likely dose
Chlorhexidine gluconate (4%) 10 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01241318
NCT01241318Phase 3Completed
CompareCT.gov

Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia

Boston University·interventional·Posted Nov 16, 2010·Updated Aug 31, 2020

In Brief

A Phase 3 clinical trial evaluating Chlorhexidine gluconate (4%) and Dry cord care for Sepsis. Completed, enrolled 77,535 participants across 1 site.

Detailed Summary

This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry cord care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesZambia
CollaboratorsBill and Melinda Gates Foundation, Ministry of Health, Zambia, Zambia Center for Applied Health Research and Development

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 16, 2010
Enrollment StartFeb 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.6 years ago

Interventions

Chlorhexidine gluconate (4%)drug

Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.

Dry cord careprocedure

Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.