NCT02863627

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

June 28, 2016

Last Update Submit

July 27, 2018

Conditions

Keywords

Emergenciesnewborncare

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

EXPERIMENTAL

two telephone interviews conducted after the emergency department visit will be used to gather data to meet the objectives of this study.

Other: Newborn Care Pathway

Interventions

consultation with the pediatric emergency, two telephone interviews to complete Questionnaires with the parents after the emergency department visit

Newborn Care Pathway

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, 06200, France

Location

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.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne-Laure HERISSE, MD

    Hôpitaux Pédiatriques de Nice CHU-LENVAL

    PRINCIPAL INVESTIGATOR

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

Locations