Contribution of a Nurse Consultation in the Follow-up of At-risk Newborn at Maternity Discharged (NURCO-NEO)

June 9, 2023 updated by: Centre Hospitalier Sud Francilien

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.

The postnatal period is a critical phase involving important physiological, psychological and social changes. 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 pediatric emergency department (PED) visits and/or hospitalization in first weeks of life. To describe population of at-risk newborns who attended a nurse consultation after discharge from a type 3 maternity hospital and to evaluate the impact of a post-hospitalization nurse consultation for at-risk newborns on PED visits and hospitalizations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

1892

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Corbeil-Essonnes, France, 91106
        • Recruiting
        • Centre Hospitalier Sud Francilien
        • Contact:
        • Principal Investigator:
          • Pauline LEROUX, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Neonates born and/or hospitalized at a tertiary center, Centre Hospitalier Sud Francilien, Corbeil Essonnes, France defined as follow.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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