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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Omphalitis

Treatments: Other: Cord care by simple debridement (soaping, rinsing and drying); Other: Cord care with the use of antiseptics

Study type: Interventional

Funder types: Other

Identifiers

NCT01556867

BRD/10/06-U

Details and patient eligibility

About

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.

Enrollment: 8,698 patients

Sex: All

Ages: 1 minute to 24 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8,698 participants in 2 patient groups

dry cord care

Active Comparator group

Treatment:

Other: Cord care by simple debridement (soaping, rinsing and drying)

antiseptic care

Active Comparator group

Treatment:

Other: Cord care with the use of antiseptics