Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT01556867
Status:
TERMINATED
Last Update Posted:
2016-08-08
First Post:
2012-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEOCORD
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: