What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year

Emergencies Clinical Trial

— NNUP  

Official title:

What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year Newborn Pediatric Emergencies (NNUP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863627
• Other study ID #: 16-HPNCL-04
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: July 2018
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: February 28, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies

Intervention

Other:
• Newborn Care Pathway
consultation with the pediatric emergency, two telephone interviews to complete Questionnaires with the parents after the emergency department visit

Locations

Country	Name	City	State
France	Hôpitaux Pédiatriques de Nice CHU-LENVAL	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of abnormal care path	description of factors associated with abnormal care path not adapted to emergencies.	baseline
Secondary	Evaluate reasons to come to pediatric emergency	Evaluate the reasons why parents of newborns consult pediatric emergency in first intention	baseline
Secondary	Evaluate the information received by parents	Evaluate the information received by parents on maternity or during medical consultations or previous paramedical	baseline