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Chlorhexidine Cord Care for Newborn Infants in Kenya

NCT02624622 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2018-05-11

No results posted yet for this study

Summary

Studies in several countries with a high rate of death of infants during the first week of life have found a reduction in infection and mortality when chlorhexidine is applied to the umbilical cord stump by a health worker within 24 hours of birth. This study will evaluate if providing chlorhexidine to pregnant women during a prenatal care visit for application to the cord stump after birth will be as effective for preventing omphalitis (infection of the umbilical cord stump) as sending a community health worker into the home to apply the chlorhexidine.

Conditions

  • Omphalitis

Interventions

PROCEDURE

Chlorhexidine application to cord by mother

PROCEDURE

Chlorhexidine application by CHW

Sponsors & Collaborators

  • University of Nairobi

    collaborator OTHER

  • University of New Mexico

    lead OTHER

Principal Investigators

  • ANGELO TOMEDI, MD · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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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 NCT02624622 on ClinicalTrials.gov