What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year
NNUP
1 other identifier
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedJuly 31, 2018
July 1, 2018
8 months
June 28, 2016
July 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline
Secondary Outcomes (3)
Evaluation of abnormal care path
baseline
Evaluate reasons to come to pediatric emergency
baseline
Evaluate the information received by parents
baseline
Study Arms (1)
Newborn Care Pathway
EXPERIMENTALtwo telephone interviews conducted after the emergency department visit will be used to gather data to meet the objectives of this study.
Interventions
consultation with the pediatric emergency, two telephone interviews to complete Questionnaires with the parents after the emergency department visit
Eligibility Criteria
You may qualify if:
- Newborn within 28 days included
- Subjects affiliated to Social Security.
- Non-opposition form signed by the two parents.
You may not qualify if:
- Parental refusal
- non opposition form not signed by the parents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondation Lenvallead
Study Sites (1)
Hôpitaux Pédiatriques de Nice CHU-LENVAL
Nice, 06200, France
Related Publications (1)
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.
PMID: 34992122DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Laure HERISSE, MD
Hôpitaux Pédiatriques de Nice CHU-LENVAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2016
First Posted
August 11, 2016
Study Start
June 1, 2016
Primary Completion
January 31, 2017
Study Completion
February 28, 2017
Last Updated
July 31, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share