Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Inc… (NCT01556867) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn
France8,698 participantsStarted 2011-03
Plain-language summary
At birth, the umbilical cord is cut, separating physically and symbolically the mother of his child. Before cord drop, umbilical area is a possible way of bacterial infection. Thus, umbilical cord infections constitute a major cause of neonatal morbidity and mortality in developing countries. In industrialized countries, omphalitis cases have almost disappeared whatever cord care strategies. At this day, care practices appear extremely different between countries, based more on habits and convictions that on evidence-based medicine. The investigators propose to conduct a non inferiority multicenter clustered crossed randomized study. Observations sessions will be performed on two consecutive periods of 5 months: 4 months of recruitment and 1 month follow-up. Main objective is to demonstrate that dry cord care practice would not expose to a higher risk of omphalitis than antiseptic based care approach. The purpose of NEOCORD study is a simplification of cord care for paramedical teams and parents, but also a significant reduction of costs in a medico-economic approach.
Who can participate
Age range
1 Minute – 24 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:
* Newborn \> 36 weeks of gestation.
* Asymptomatic newborn hospitalization.
* Information and consent of parental or legal authority.
Exclusion Criteria:
* Outborn.
* Family or social environment considered incompatible with dry cord care by investigator from a hygienic point of view (no fixed abode etc…).
* Hospitalization in neonatal intensive care unit.
* Transfer to another maternity hospital.
* Gestational age less than or equal to 36 weeks of gestation.
* Serious Congenital Pathology.
* Opposition of parents.
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
1
The incidence of occurrence of omphalitis within 28 days post-birth in omphalitis incidence in healthy newborn