NCT01556867

Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,698 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 1 Minute – 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Omphalitis

Interventions

Type	Name	Description
OTHER	Cord care by simple debridement (soaping, rinsing and drying)	For children born during an experimental period of cord care will be done with a simple debridement (soaping and then rinsing and drying carefully)
OTHER	Cord care with the use of antiseptics	For children born during a control period, cord care will be done with an antiseptic whose choice is left to the discretion of the healthcare team. In this essay, it opted not to impose an antiseptic. Indeed, the objective of the trial is to compare the two strategies for management of care.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-03-16
• Last updated: 2016-08-08

Locations

6 sites across 1 country: France