- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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)
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Nice, Francie, 06200
- Hôpitaux Pédiatriques de Nice CHU-Lenval
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Evaluation course of care of newborns
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Evaluation of abnormal care path
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 16-HPNCL-04
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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