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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01556867
Recruitment Status : Terminated
First Posted : March 16, 2012
Last Update Posted : August 8, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Omphalitis Other: Cord care by simple debridement (soaping, rinsing and drying) Other: Cord care with the use of antiseptics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8698 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : March 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Active Comparator: dry cord care 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)

Active Comparator: antiseptic care Other: 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.

Primary Outcome Measures :
  1. The incidence of occurrence of omphalitis within 28 days post-birth in omphalitis incidence in healthy newborn [ Time Frame: 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 :
  1. Occurrence of neonatal infection defined as any situation requiring hospitalization and antibiotics in the first month of life [ Time Frame: 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.

  2. Date of the fall of the umbilical cord [ Time Frame: 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.

  3. Description of bacterial flora in umbilical waning of omphalitis [ Time Frame: 13 months ]
    Regarding the bacterial flora, the analysis will be descriptive.

  4. Parental satisfaction [ Time Frame: 13 months ]
    Parental satisfaction, rated using a scale of 0 to 10, will be analyzed using a hierarchical model for quantitative data.

  5. Occurrence of an infection or néonatlale maternal postpartum [ Time Frame: 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.

  6. State immunization against pertussis parental [ Time Frame: 13 months ]
  7. Sleeping patterns of children in the first months of life [ Time Frame: 13 months ]
    Description of the sleeping patterns

  8. Diet of the child at day 28. [ Time Frame: 13 months ]
    Description of the infant feeding

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01556867

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Dr SAVAGNER Christophe
Angers, France
Brest, France
Nantes, France
Poitiers, France
Pr PLADYS Patrick
Rennes, France
Tours, France
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Christèle GRAS-LE GUEN, PH CHU de Nantes
Principal Investigator: Christophe SAVAGNER, PH University Hospital, Angers
Principal Investigator: Patrick PLADYS, PU-PH Rennes University Hospital
Principal Investigator: Elie SALIBA, PU-PH CHU de Tours
Principal Investigator: Gisèle GREMMO-FREGER, PH CHU de Brest
Principal Investigator: Emmanuelle DESCOMBES-BARROSO, PH Poitiers University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nantes University Hospital Identifier: NCT01556867    
Other Study ID Numbers: BRD/10/06-U
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Keywords provided by Nantes University Hospital:
Umbilical cord care
dry cord care
umbilical cord drop
hospitalized in maternity hospital
Additional relevant MeSH terms:
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Anti-Infective Agents, Local
Anti-Infective Agents