OmphalitisNEOCORDNCT01556867
Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn
A study testing Cord care by simple debridement (soaping, rinsing and drying) and Cord care with the use of antiseptics in people with Omphalitis, run by Nantes University Hospital at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 24 hours
- Conditions the study is for
- Omphalitis
- What is being tested?
- Cord care by simple debridement (soaping, rinsing and drying) and Cord care with the use of antiseptics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,698 participants
- Where
- 6 sitesFrance
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn > 36 weeks of gestation.
- Asymptomatic newborn hospitalization.
- Information and consent of parental or legal authority.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Dr SAVAGNER Christophe
Angers
Dr GREMMO-FREGER Gisèle
Brest
Dr GRAS-LEGUEN
Nantes
Dr DESCOMBES-BARROSO Emmanuelle
Poitiers
Pr PLADYS Patrick
Rennes
Pr SALIBA Elie
Tours
About this study
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
- Being tested
- Cord care by simple debridement (soaping, rinsing and drying), Cord care with the use of antiseptics
- Keywords
- Umbilical cord care, dry cord care, antiseptic, Omphalitis, umbilical cord drop, hospitalized in maternity hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Cord care with the use of antisepticsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| dry cord care | Active comparator | Not described Receives: Other: Cord care by simple debridement (soaping, rinsing and drying) |
| antiseptic care | Active comparator | Not described Receives: Other: Cord care with the use of antiseptics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 months
Secondary outcomes (8)
Occurrence of neonatal infection defined as any situation requiring hospitalization and antibiotics in the first month of life
The analysis of the occurrence of neonatal infection will be conducted using the same strategy as that used for the primary outcome measure.
Measured: 13 months
Date of the fall of the umbilical cord
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.
Measured: 13 months
Description of bacterial flora in umbilical waning of omphalitis
Regarding the bacterial flora, the analysis will be descriptive.
Measured: 13 months
Parental satisfaction
Parental satisfaction, rated using a scale of 0 to 10, will be analyzed using a hierarchical model for quantitative data.
Measured: 13 months
Occurrence of an infection or néonatlale maternal postpartum
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.
Measured: 13 months
State immunization against pertussis parental
Measured: 13 months
Sleeping patterns of children in the first months of life
Description of the sleeping patterns
Measured: 13 months
Diet of the child at day 28.
Description of the infant feeding
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OmphalitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8,698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christèle GRAS-LE GUEN, PH, Principal investigator, Nantes University HospitalChristophe SAVAGNER, PH, Principal investigator, University Hospital, AngersPatrick PLADYS, PU-PH, Principal investigator, Rennes University HospitalElie SALIBA, PU-PH, Principal investigator, CHU de ToursGisèle GREMMO-FREGER, PH, Principal investigator, CHU de BrestEmmanuelle DESCOMBES-BARROSO, PH, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556867
- Sponsor's protocol ID
- BRD/10/06-U
- Acronym
- NEOCORD
- Status last verified
- Aug 2016
- First submitted
- 17 Feb 2012
- Last updated
- 8 Aug 2016
- Results posted
- No
Publications
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.
PubMed 28008096
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Strategies for Umbilical Cord Care : Dry Cord Care Versus Antiseptic on the Incidence of Omphalitis in Healthy Term Newborn
- ClinicalTrials.gov ID
- NCT01556867
- Acronym / sponsor ID
- NEOCORD / BRD/10/06-U
- Conditions
- Omphalitis
- Keywords
- Umbilical cord care, dry cord care, antiseptic, Omphalitis, umbilical cord drop, hospitalized in maternity hospital
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8,698 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 minute to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborn > 36 weeks of gestation.
- Asymptomatic newborn hospitalization.
- Information and consent of parental or legal authority.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | dry cord care |
| Cord care with the use of antisepticsFor 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. | Other | antiseptic care |
Primary outcome
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.
8 secondary outcomes
Occurrence of neonatal infection defined as any situation requiring hospitalization and antibiotics in the first month of life
Time frame: 13 months
Date of the fall of the umbilical cord
Time frame: 13 months
Description of bacterial flora in umbilical waning of omphalitis
Time frame: 13 months
Parental satisfaction
Time frame: 13 months
Occurrence of an infection or néonatlale maternal postpartum
Time frame: 13 months
State immunization against pertussis parental
Time frame: 13 months
Sleeping patterns of children in the first months of life
Time frame: 13 months
Diet of the child at day 28.
Time frame: 13 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Derived from this study: PubMed 28008096Gras-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christèle GRAS-LE GUEN, PH principal investigator
Nantes University Hospital
Christophe SAVAGNER, PH principal investigator
University Hospital, Angers
Patrick PLADYS, PU-PH principal investigator
Rennes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cord care by simple debridement (soaping, rinsing and drying) and Cord care with the use of antiseptics in people with Omphalitis, run by Nantes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of occurrence of omphalitis within 28 days post-birth in omphalitis incidence in healthy newborn (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01556867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.