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

Study Overview
=================
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.

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

Conditions
-----------------
Omphalitis

Intervention / Treatment
-----------------
* Other: Cord care by simple debridement (soaping, rinsing and drying)
* Other: Cord care with the use of antiseptics


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 24 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dry cord care<br> | Other: Cord care by simple debridement (soaping, rinsing and drying)<br>* For children born during an experimental period of cord care will be done with a simple debridement (soaping and then rinsing and drying carefully)<br>|
| Active Comparator: antiseptic care<br> | Other: Cord care with the use of antiseptics<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of occurrence of omphalitis within 28 days post-birth in omphalitis incidence in healthy newborn | The primary endpoint will correspond to the incidence of omphalitis occurred within 28 days post-birth. The omphalitis is defined as the presence of erythema or serous or purulent in-cord tissue or umbilical perished. The stages are described to investigators about watching information in a search for suspected omphalitis. This can be confirmed retrospectively by an Awards Committee composed of a Dermatopédiatre, a pediatrician and a pediatric surgeon. | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of neonatal infection defined as any situation requiring hospitalization and antibiotics in the first month of life | The analysis of the occurrence of neonatal infection will be conducted using the same strategy as that used for the primary outcome measure. | 13 months | 
| Date of the fall of the umbilical cord | The analysis of time to drop cord will also be conducted as part of a hierarchical model by considering a quantitative endpoint. If necessary, a transformation will be applied to the data before analysis. | 13 months | 
| Description of bacterial flora in umbilical waning of omphalitis | Regarding the bacterial flora, the analysis will be descriptive. | 13 months | 
| Parental satisfaction | Parental satisfaction, rated using a scale of 0 to 10, will be analyzed using a hierarchical model for quantitative data. | 13 months | 
| Occurrence of an infection or néonatlale maternal postpartum | Finally, concerning data on the health of mother and child (maternal infection, pertussis vaccination, sleeping habits, diet of the child), the analysis is purely descriptive. | 13 months | 
| State immunization against pertussis parental |  | 13 months | 
| Sleeping patterns of children in the first months of life | Description of the sleeping patterns | 13 months | 
| Diet of the child at day 28. | Description of the infant feeding | 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Umbilical cord care, dry cord care, antiseptic, Omphalitis, umbilical cord drop, hospitalized in maternity hospital