Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn (NEOCORD)
|ClinicalTrials.gov Identifier: NCT01556867|
Recruitment Status : Terminated
First Posted : March 16, 2012
Last Update Posted : August 8, 2016
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8698 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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.
- 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.
- Description of bacterial flora in umbilical waning of omphalitis [ Time Frame: 13 months ]Regarding the bacterial flora, the analysis will be descriptive.
- 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.
- 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.
- State immunization against pertussis parental [ Time Frame: 13 months ]
- Sleeping patterns of children in the first months of life [ Time Frame: 13 months ]Description of the sleeping patterns
- Diet of the child at day 28. [ Time Frame: 13 months ]Description of the infant feeding
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556867
|Dr SAVAGNER Christophe|
|Dr GREMMO-FREGER Gisèle|
|Dr DESCOMBES-BARROSO Emmanuelle|
|Pr PLADYS Patrick|
|Pr SALIBA Elie|
|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|