Clinical trial NCT01556867: Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn
Official title: Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Omphalitis
Keywords: Umbilical cord care
dry cord care
antiseptic
Omphalitis
umbilical cord drop
hospitalized in maternity hospital
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 8698
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: The incidence of occurrence of omphalitis within 28 days post-birth in omphalitis incidence in healthy newborn
timeFrame: 13 months
Secondary outcomes:
measure: Occurrence of neonatal infection defined as any situation requiring hospitalization and antibiotics in the first month of life
timeFrame: 13 months
measure: Date of the fall of the umbilical cord
timeFrame: 13 months
measure: Description of bacterial flora in umbilical waning of omphalitis
timeFrame: 13 months
measure: Parental satisfaction
timeFrame: 13 months
measure: Occurrence of an infection or néonatlale maternal postpartum
timeFrame: 13 months
measure: State immunization against pertussis parental
timeFrame: 13 months
measure: Sleeping patterns of children in the first months of life
timeFrame: 13 months
measure: Diet of the child at day 28.
timeFrame: 13 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Dr SAVAGNER Christophe
city: Brest
country: France
facility: Dr GREMMO-FREGER Gisèle
city: Nantes
country: France
facility: Dr GRAS-LEGUEN
city: Poitiers
country: France
facility: Dr DESCOMBES-BARROSO Emmanuelle
city: Rennes
country: France
facility: Pr PLADYS Patrick
city: Tours
country: France
facility: Pr SALIBA Elie
Study officials:
affiliation: Nantes University Hospital
name: Christèle GRAS-LE GUEN, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Christophe SAVAGNER, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Patrick PLADYS, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Tours
name: Elie SALIBA, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Brest
name: Gisèle GREMMO-FREGER, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Poitiers University Hospital
name: Emmanuelle DESCOMBES-BARROSO, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gras-Le Guen C, Caille A, Launay E, Boscher C, Godon N, Savagner C, Descombes E, Gremmo-Feger G, Pladys P, Saillant D, Legrand A, Caillon J, Barbarot S, Roze JC, Giraudeau B. Dry Care Versus Antiseptics for Umbilical Cord Care: A Cluster Randomized Trial. Pediatrics. 2017 Jan;139(1):e20161857. doi: 10.1542/peds.2016-1857.