MedTrace Logo

Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis

NCT01528852 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36911

Last updated 2023-08-28

No results posted yet for this study

Summary

In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life results in

* Reduction in neonatal mortality (deaths in first 28 days of life)
* Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life
* Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life.

The double blind part of study uses a control preparation without chlorhexidine (CHX) as control group while in the sub-study dry cord care group is also evaluated as second control. Hypothesis is that CHX group will have lower mortality and umbilical cord infections while control group and dry cord group will be similar as shown in a previous study in Nepal.

Conditions

  • Neonatal Mortality
  • Cord Care
  • Omphalitis

Interventions

DRUG

Chlorhexidine 4%

4% liquid solution used for cord cleaning once daily for 10 days

DRUG

Chlorhexidine 4%

Chlorhexidine 4% liquid solution used for cord cleaning once daily for 10 days

OTHER

Control cord cleaning solution

Mild soapy solution used to clean cord once daily for 10 days

Sponsors & Collaborators

  • Annamalai University

    collaborator OTHER

  • Ministry of Health and Social Welfare, Zanzibar

    collaborator OTHER_GOV

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-19
Primary Completion
2014-09-29
Completion
2014-09-29

Countries

  • Tanzania

Study Locations

More Related Trials

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 NCT01528852 on ClinicalTrials.gov