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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01556867
First received: February 17, 2012
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • The incidence of occurrence of omphalitis within 28 days post-birth in omphalitis incidence in healthy newborn [ Time Frame: 13 months ] [ Designated as safety issue: No ]

    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:
  • Occurrence of neonatal infection defined as any situation requiring hospitalization and antibiotics in the first month of life [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    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.

  • Description of bacterial flora in umbilical waning of omphalitis [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    Regarding the bacterial flora, the analysis will be descriptive.

  • Parental satisfaction [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    Parental satisfaction, rated using a scale of 0 to 10, will be analyzed using a hierarchical model for quantitative data.

  • Occurrence of an infection or néonatlale maternal postpartum [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    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.

  • State immunization against pertussis parental [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Sleeping patterns of children in the first months of life [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    Description of the sleeping patterns

  • Diet of the child at day 28. [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    Description of the infant feeding


Enrollment: 8698
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556867

Locations
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, France
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01556867     History of Changes
Other Study ID Numbers: 10/06-U
Study First Received: February 17, 2012
Last Updated: January 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Umbilical cord care
dry cord care
antiseptic
Omphalitis
umbilical cord drop
hospitalized in maternity hospital

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014