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Zambia Chlorhexidine Application Trial

NCT01241318 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 77535

Last updated 2020-08-31

Study results available
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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.

Conditions

Interventions

DRUG

Chlorhexidine gluconate (4%)

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.

PROCEDURE

Dry cord care

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.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Ministry of Health, Zambia

    collaborator OTHER_GOV

  • Zambia Center for Applied Health Research and Development

    collaborator OTHER

  • Boston University

    lead OTHER

Principal Investigators

  • Davidson H Hamer, MD · Boston University Center for Global Health and Development

  • Katherine Semrau, PhD · Boston University Center for Global Health and Development

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01241318 on ClinicalTrials.gov