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

August 5, 2016 updated by: Nantes University Hospital
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8698

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Dr SAVAGNER Christophe
      • Brest, France
        • Dr GREMMO-FREGER Gisèle
      • Nantes, France
        • Dr GRAS-LEGUEN
      • Poitiers, France
        • Dr DESCOMBES-BARROSO Emmanuelle
      • Rennes, France
        • Pr PLADYS Patrick
      • Tours, France
        • Pr SALIBA Elie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 day (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 months
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.
13 months
Description of bacterial flora in umbilical waning of omphalitis
Time Frame: 13 months
Regarding the bacterial flora, the analysis will be descriptive.
13 months
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.
13 months
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.
13 months
State immunization against pertussis parental
Time Frame: 13 months
13 months
Sleeping patterns of children in the first months of life
Time Frame: 13 months
Description of the sleeping patterns
13 months
Diet of the child at day 28.
Time Frame: 13 months
Description of the infant feeding
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (ESTIMATE)

March 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/10/06-U

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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