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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8698 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Omphalitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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dry cord care

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

For children born during an experimental period of cord care will be done with a simple debridement (soaping and then rinsing and drying carefully)

antiseptic care

Group Type ACTIVE_COMPARATOR

Cord care with the use of antiseptics

Intervention Type OTHER

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.

Interventions

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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)

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

1 Minute

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No