CompletedPhase 3

Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis

Tanzania36,911 participantsStarted 2011-05-19

Plain-language 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.

Who can participate

Age range

1 Hour – 48 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Permanent resident of Pemba * Consenting to participate, infants alive at first contact with MCH/TBA/Hospital staff * First contact within 48 hours of delivery. Exclusion Criteria: * Congenital malformations where application of intervention is not possible * Very sick child needing hospitalization and ICU care.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neonatal Mortality

Timeframe: 28 days after birth

Trial details

NCT IDNCT01528852

SponsorJohns Hopkins Bloomberg School of Public Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09-29

View on ClinicalTrials.gov More Neonatal Mortality trials