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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8,698
For children born during an experimental period of cord care will be done with a simple debridement (soaping and then rinsing and drying carefully)
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.
Dr SAVAGNER Christophe
Angers, France
Dr GREMMO-FREGER Gisèle
Brest, France
Dr GRAS-LEGUEN
Nantes, France
Dr DESCOMBES-BARROSO Emmanuelle
Poitiers, France
Pr PLADYS Patrick
Rennes, France
Pr SALIBA Elie
Tours, France
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.
Time frame: 13 months
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.
Time frame: 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.
Time frame: 13 months
Description of bacterial flora in umbilical waning of omphalitis
Regarding the bacterial flora, the analysis will be descriptive.
Time frame: 13 months
Parental satisfaction
Parental satisfaction, rated using a scale of 0 to 10, will be analyzed using a hierarchical model for quantitative data.
Time frame: 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.
Time frame: 13 months
State immunization against pertussis parental
Time frame: 13 months
Sleeping patterns of children in the first months of life
Description of the sleeping patterns
Time frame: 13 months
Diet of the child at day 28.
Description of the infant feeding
Time frame: 13 months
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