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

NCT01556867 | Terminated

• 1 other identifier: BRD/10/06-U
• Study Type: interventional
• Target: 8,698
• Locations: 1 country
• Sites: 6

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.

Conditions

Omphalitis

Keywords

Umbilical cord care; dry cord care; antiseptic; Omphalitis; umbilical cord drop; hospitalized in maternity hospital

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Occurrence of neonatal infection defined as any situation requiring hospitalization and antibiotics in the first month of life

  13 months

• Date of the fall of the umbilical cord

  13 months

• Description of bacterial flora in umbilical waning of omphalitis

  13 months

• Parental satisfaction

  13 months

• Occurrence of an infection or néonatlale maternal postpartum

  13 months

Study Arms (2)

dry cord care

ACTIVE COMPARATOR

Other: Cord care by simple debridement (soaping, rinsing and drying)

antiseptic care

ACTIVE COMPARATOR

Other: Cord care with the use of antiseptics

Interventions

Cord care by simple debridement (soaping, rinsing and drying) OTHER

For children born during an experimental period of cord care will be done with a simple debridement (soaping and then rinsing and drying carefully)

dry cord care

Cord care with the use of antiseptics OTHER

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.

antiseptic care

Eligibility Criteria

• Age: 1 Minute - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn \> 36 weeks of gestation.
• Asymptomatic newborn hospitalization.
• Information and consent of parental or legal authority.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

Dr SAVAGNER Christophe

Angers, France

Location

Dr GREMMO-FREGER Gisèle

Brest, France

Location

Dr GRAS-LEGUEN

Nantes, France

Location

Dr DESCOMBES-BARROSO Emmanuelle

Poitiers, France

Location

Pr PLADYS Patrick

Rennes, France

Location

Pr SALIBA Elie

Tours, France

Location

Related Publications (1)

• Gras-Le Guen C, Caille A, Launay E, Boscher C, Godon N, Savagner C, Descombes E, Gremmo-Feger G, Pladys P, Saillant D, Legrand A, Caillon J, Barbarot S, Roze JC, Giraudeau B. Dry Care Versus Antiseptics for Umbilical Cord Care: A Cluster Randomized Trial. Pediatrics. 2017 Jan;139(1):e20161857. doi: 10.1542/peds.2016-1857.

  PMID: 28008096 DERIVED

MeSH Terms

Interventions

Desiccation

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Christèle GRAS-LE GUEN, PH

  Nantes University Hospital

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

FR (6)