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EmergenciesNNUPNCT02863627

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

A study testing Newborn Care Pathway in people with Emergencies, run by Fondation Lenval at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 28 days
Conditions the study is for
Emergencies
What is being tested?
Newborn Care Pathway
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteFrance
Study dates
Jun 2016to 28 Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Newborn within 28 days included
  • Subjects affiliated to Social Security.
  • Non-opposition form signed by the two parents.

Who cannot join

  • Parental refusal
  • non opposition form not signed by the parents.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpitaux Pédiatriques de Nice CHU-LENVAL

    Nice, 06200

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Emergencies
Being tested
Newborn Care Pathway
Keywords
Emergencies, newborn, care
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Newborn Care PathwayOther

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

Study groups in NCT02863627
Study groupRoleWhat they receive
Newborn Care PathwayExperimentaltwo telephone interviews conducted after the emergency department visit will be used to gather data to meet the objectives of this study.
Receives: Other: Newborn Care Pathway

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline

Secondary outcomes (3)
  1. Evaluation of abnormal care path

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

    Measured: baseline

  2. Evaluate reasons to come to pediatric emergency

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

    Measured: baseline

  3. Evaluate the information received by parents

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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion31 Jan 2017
  4. Study completion28 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02863627
Sponsor's protocol ID
16-HPNCL-04
Acronym
NNUP
Status last verified
Jul 2018
First submitted
28 Jun 2016
Last updated
31 Jul 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34992122

Questions about this trial

What is this clinical trial studying?

A study testing Newborn Care Pathway in people with Emergencies, run by Fondation Lenval at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation course of care of newborns (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02863627, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.

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