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

Omphalitis Clinical Trial

— NEOCORD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01556867
• Other study ID #: BRD/10/06-U
• Status: Terminated
• Phase: N/A
• First received: February 17, 2012
• Last updated: August 5, 2016
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8698
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Omphalitis

Intervention

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)
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Description of bacterial flora in umbilical waning of omphalitis	Regarding the bacterial flora, the analysis will be descriptive.	13 months	No
Secondary	Parental satisfaction	Parental satisfaction, rated using a scale of 0 to 10, will be analyzed using a hierarchical model for quantitative data.	13 months	No
Secondary	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	No
Secondary	State immunization against pertussis parental		13 months	No
Secondary	Sleeping patterns of children in the first months of life	Description of the sleeping patterns	13 months	No
Secondary	Diet of the child at day 28.	Description of the infant feeding	13 months	No