- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02863627
What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year (NNUP)
What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year Newborn Pediatric Emergencies (NNUP)
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Nice, Francia, 06200
- Hôpitaux Pédiatriques de Nice CHU-Lenval
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Newborn Care Pathway
two telephone interviews conducted after the emergency department visit will be used to gather data to meet the objectives of this study.
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consultation with the pediatric emergency, two telephone interviews to complete Questionnaires with the parents after the emergency department visit
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Evaluation course of care of newborns
Lasso di tempo: baseline
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Evaluate the course of care of newborns consultant pediatric emergencies as recommended by the National Health Authority in 2014.
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baseline
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Evaluation of abnormal care path
Lasso di tempo: baseline
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description of factors associated with abnormal care path not adapted to emergencies.
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baseline
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Evaluate reasons to come to pediatric emergency
Lasso di tempo: baseline
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Evaluate the reasons why parents of newborns consult pediatric emergency in first intention
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baseline
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Evaluate the information received by parents
Lasso di tempo: baseline
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Evaluate the information received by parents on maternity or during medical consultations or previous paramedical
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baseline
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 16-HPNCL-04
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .