What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year (NNUP)
Primary Purpose
Emergencies
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Newborn Care Pathway
Sponsored by
About this trial
This is an interventional other trial for Emergencies focused on measuring Emergencies, newborn, care
Eligibility Criteria
Inclusion Criteria:
- Newborn within 28 days included
- Subjects affiliated to Social Security.
- Non-opposition form signed by the two parents.
Exclusion Criteria:
- Parental refusal
- non opposition form not signed by the parents.
Sites / Locations
- Hôpitaux Pédiatriques de Nice CHU-LENVAL
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Newborn Care Pathway
Arm Description
two telephone interviews conducted after the emergency department visit will be used to gather data to meet the objectives of this study.
Outcomes
Primary Outcome Measures
Evaluation course of care of newborns
Evaluate the course of care of newborns consultant pediatric emergencies as recommended by the National Health Authority in 2014.
Secondary Outcome Measures
Evaluation of abnormal care path
description of factors associated with abnormal care path not adapted to emergencies.
Evaluate reasons to come to pediatric emergency
Evaluate the reasons why parents of newborns consult pediatric emergency in first intention
Evaluate the information received by parents
Evaluate the information received by parents on maternity or during medical consultations or previous paramedical
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02863627
Brief Title
What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year
Acronym
NNUP
Official Title
What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year Newborn Pediatric Emergencies (NNUP)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the course of care of newborns, to understand why some newborns have improper care pathways, particularly as regards the first medical consultation at the exit of motherhood. It is also to organize a better quality care network to hospital discharge to avoid unnecessary use of pediatric emergencies, which represents a real public health problem.
Detailed Description
In 2014, newborns represented 1.57% of passages (or 906 newborns) of Emergency Pediatric Hospitals CHU de Nice-Lenval. This proportion is significant and steadily increasing (2013: 820 newborns or 1.46% of passes). The experienced team of pediatric emergency is that the majority of consultations respite care and child care could well be managed city. The bibliographic data confirms this feeling.
But no study has examined the course of care of the newborn during its first month of life. In 2014, in its recommendations for good practice for the release of motherhood after giving birth, the HAS recommends a medical examination by a pediatrician (or a general practitioner with experience of pathologies of the newborn) between 6 and 10 days of life. Other consultations (midwife, health visitor in PMI) is not required. Moreover, in its brochure to mothers, prompt medical attention is recommended in certain situations (fever, vomiting ...) but without specifying the organization. The pediatric emergency therefore no place, except for emergencies, in the course of care of newborns. But the care pathway proposed by the HAS is it feasible? And it reduces unnecessary use of pediatric emergency?
The main objective of this study is to evaluate the course of care of newborns consultant pediatric emergency looks to the recommendations of the 2014 HAS.
The secondary objectives are:
Identify factors associated with abnormal care course and / or consultation with appropriate non emergencies.
Evaluate the reasons why parents of newborns to consult pediatric emergency first-line concern and before / after the emergency department visit.
Evaluate the information received by parents on maternity or during medical consultations or previous paramedical.
The primary endpoint is the assessment of the course of care of newborns consultant pediatric emergencies of appropriately (that is to say addressed newborn and / or implementation of additional tests and / or hospitalization) or not adapted.
The secondary endpoints are:
Description of clinical and demographic characteristics of the newborn, the social characteristics of the parents.
Description of the consultation to pediatric emergencies.
Information Evaluation received by parents on the time of the first medical consultation at the exit of motherhood and the reason for consultation to pediatric emergencies.
This is a biomedical intervention study Routine care, single-center prospective, non-randomized. Will be included all newborns (that is to say, child ≤ 28 days of life) consultant to hospital emergency NICE-Lenval Hospital, and after obtaining the non-opposition of the two parents. The number of patients needed is 280 newborns. The duration of inclusion is one year.
Following consultation with the pediatric emergency, parents will be contacted 2 times:
2-7 days after the consultation: clinical and demographic characteristics of the newborn, social characteristics of parents, information received by parents, whether (s) consultation (s) Medical (s) or paramedic (s) already completed and anxiety parents before / after the emergency department visit.
In the week following the first month of life the child complete the child care course.
The data on emergency department visit (which made additional tests and fate of the child) will be collected from the host software pediatric emergencies.
This study will evaluate the course of care of newborns, to understand why some newborns have improper care pathways, particularly as regards the first medical consultation at the exit of motherhood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
Keywords
Emergencies, newborn, care
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Newborn Care Pathway
Arm Type
Experimental
Arm Description
two telephone interviews conducted after the emergency department visit will be used to gather data to meet the objectives of this study.
Intervention Type
Other
Intervention Name(s)
Newborn Care Pathway
Intervention Description
consultation with the pediatric emergency, two telephone interviews to complete Questionnaires with the parents after the emergency department visit
Primary Outcome Measure Information:
Title
Evaluation course of care of newborns
Description
Evaluate the course of care of newborns consultant pediatric emergencies as recommended by the National Health Authority in 2014.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Evaluation of abnormal care path
Description
description of factors associated with abnormal care path not adapted to emergencies.
Time Frame
baseline
Title
Evaluate reasons to come to pediatric emergency
Description
Evaluate the reasons why parents of newborns consult pediatric emergency in first intention
Time Frame
baseline
Title
Evaluate the information received by parents
Description
Evaluate the information received by parents on maternity or during medical consultations or previous paramedical
Time Frame
baseline
10. Eligibility
Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newborn within 28 days included
Subjects affiliated to Social Security.
Non-opposition form signed by the two parents.
Exclusion Criteria:
Parental refusal
non opposition form not signed by the parents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Laure HERISSE, MD
Organizational Affiliation
Hôpitaux Pédiatriques de Nice CHU-LENVAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Pédiatriques de Nice CHU-LENVAL
City
Nice
ZIP/Postal Code
06200
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34992122
Citation
Tran A, Herisse AL, Isoardo M, Valo P, Maillotte AM, Haas H, Donzeau D, Freyssinet E, Pradier C, Gentile S. Evaluation of compliance with early postbirth follow-up and unnecessary visits to the paediatric emergency department: a prospective observational study at the Lenval Children's Hospital in Nice. BMJ Open. 2022 Jan 6;12(1):e056476. doi: 10.1136/bmjopen-2021-056476.
Results Reference
derived
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What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year
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