TerminatedNot Applicable

Chlorhexidine Cord Care for Newborn Infants in Kenya

Stopped: Lack of funds

United States576 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

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: All pregnant women who are 18 years of age or older (based on their stated date of birth) who attend the two selected health care facilities (Kisesini Dispensary and Katangi Health Center) for their prenatal care will be eligible to participate if they reside in one of the villages of the five sublocations of the target region (Kyua, Makusya, Katangi, Mekilingi, Syokisinga) and they plan to deliver within the target region - Exclusion Criteria: Pregnant women who plan to deliver outside of the target area or plan to be away from the area during the newborn infant's first week of life will be excluded \-

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

Number of infants age 0 to 7 days who develop omphalitis

Timeframe: 7 days after birth

Trial details

NCT IDNCT02624622

SponsorUniversity of New Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01

View on ClinicalTrials.gov More Omphalitis trials