- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05258916
Contribution of a Nurse Consultation in the Follow-up of At-risk Newborn at Maternity Discharged (NURCO-NEO)
Feasibility and Contribution of a Nurse Consultation in the Follow-up of At-risk Newborn at Maternity Discharged: 3-year Experience in a Tertiary Center.
Study Overview
Detailed Description
The postnatal period is a critical phase involving important physiological, psychological and social changes. In 2013, WHO recommends at least three postnatal contacts on day 3, between days 7 and 14, and six weeks after birth. Despite these recommendations, pediatric emergency department (PED) visits for newborns are constantly increasing. Some studies have shown that most of these visits were related to nonserious diseases, mainly due to a lack of knowledge and information. At the same time, some high-risk newborns have been identified as likely to be admitted to PED and subsequently hospitalized. All these findings highlight the great need for education and parental support by health staff from the time of maternity discharged, particularly when certain high-risk conditions are identified.
In France, guidelines on maternity discharge after childbirth include pediatric nurses as professionals involved in postnatal follow-up. Pediatric nurses could be a crucial actor in the follow-up of at-risk newborn, in collaboration with other health professionals and contribute to a reduction in PED visits and/or hospitalization in first weeks of life.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pauline LEROUX, MD
- Phone Number: 07 72 33 05 63
- Email: pauline.leroux03@gmail.com
Study Contact Backup
- Name: Caroline TOURTE GROSPIRON
- Phone Number: 01 61 69 31 50
- Email: caroline.tourte@chsf.fr
Study Locations
-
-
-
Corbeil-Essonnes, France, 91106
- Recruiting
- Centre Hospitalier Sud Francilien
-
Contact:
- Pauline LEROUX, MD
- Phone Number: 07 72 33 05 63
- Email: pauline.leroux03@gmail.com
-
Principal Investigator:
- Pauline LEROUX, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All at-risk newborns addressed to nurse consultation after discharge from maternity hospital.
- All at-risk newborns discharged home after hospitalization at birth in the neonatal medicine department.
Exclusion Criteria:
- Newborns discharged with home hospitalization
- Consultation for hearing screening, blood testing or injection (vaccines or palivizumab).
- Newborns referred by pediatrics department, PED or by exterior professionals.
- Non-at-risk newborns hospitalized for other reasons (biological anoxia, early neonatal bacterial infection, transient tachypnea, monitoring)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PED visits at 2 weeks
Time Frame: 2 weeks after discharge of maternity hospital
|
Number and causes of PED visits
|
2 weeks after discharge of maternity hospital
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PED visits at 3 months
Time Frame: 3 months after discharge of maternity hospital
|
Number and causes of PED visits
|
3 months after discharge of maternity hospital
|
Hospitalization
Time Frame: 3 months after discharge of maternity hospital
|
Number and causes of hospitalizations
|
3 months after discharge of maternity hospital
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022/0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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