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Completed

NCT Number: NCT02863627

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

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.

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Key information

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, 06200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Newborn Care Pathway

Other

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

Primary outcomes

  1. Evaluation course of care of newborns

    Time frame: baseline

    Evaluate the course of care of newborns consultant pediatric emergencies as recommended by the National Health Authority in 2014.

Secondary outcomes

  1. Evaluation of abnormal care path

    Time frame: baseline

    description of factors associated with abnormal care path not adapted to emergencies.

  2. Evaluate reasons to come to pediatric emergency

    Time frame: baseline

    Evaluate the reasons why parents of newborns consult pediatric emergency in first intention

  3. Evaluate the information received by parents

    Time frame: baseline

    Evaluate the information received by parents on maternity or during medical consultations or previous paramedical

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

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

Acronym: NNUP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2016
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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