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

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

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.

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Christèle GRAS-LE GUEN, PH · Nantes University Hospital

• Christophe SAVAGNER, PH · University Hospital, Angers

• Patrick PLADYS, PU-PH · Rennes University Hospital

• Elie SALIBA, PU-PH · CHU de Tours

• Gisèle GREMMO-FREGER, PH · CHU de Brest

• Emmanuelle DESCOMBES-BARROSO, PH · Poitiers University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

1 Minute

Max Age

24 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2012-03-31

Completion

2012-03-31

Countries

• France

Study Locations