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

Not Applicable

Terminated

• Conditions: Omphalitis
• Interventions: Other: Cord care by simple debridement (soaping, rinsing and drying); Other: Cord care with the use of antiseptics

• Registration Number: NCT01556867
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-02-17
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-05
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8698

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
dry cord care	Cord care by simple debridement (soaping, rinsing and drying)	-
antiseptic care	Cord care with the use of antiseptics	-

Primary Outcome Measures

Name	Time	Method
The incidence of occurrence of omphalitis within 28 days post-birth in omphalitis incidence in healthy newborn	13 months	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.

Secondary Outcome Measures

Name	Time	Method
Parental satisfaction	13 months	Parental satisfaction, rated using a scale of 0 to 10, will be analyzed using a hierarchical model for quantitative data.
Occurrence of neonatal infection defined as any situation requiring hospitalization and antibiotics in the first month of life	13 months	The analysis of the occurrence of neonatal infection will be conducted using the same strategy as that used for the primary outcome measure.
Date of the fall of the umbilical cord	13 months	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.
State immunization against pertussis parental	13 months
Diet of the child at day 28.	13 months	Description of the infant feeding
Description of bacterial flora in umbilical waning of omphalitis	13 months	Regarding the bacterial flora, the analysis will be descriptive.
Occurrence of an infection or néonatlale maternal postpartum	13 months	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.
Sleeping patterns of children in the first months of life	13 months	Description of the sleeping patterns

Trial Locations

Locations (6)

Dr GREMMO-FREGER Gisèle; 🇫🇷 Brest, France

Pr SALIBA Elie; 🇫🇷 Tours, France

Pr PLADYS Patrick; 🇫🇷 Rennes, France

Dr SAVAGNER Christophe; 🇫🇷 Angers, France

Dr GRAS-LEGUEN; 🇫🇷 Nantes, France

Dr DESCOMBES-BARROSO Emmanuelle; 🇫🇷 Poitiers, France