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.
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.
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 group | Role | What they receive |
|---|---|---|
| Newborn Care Pathway | Experimental | two 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.
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)
Evaluation of abnormal care path
description of factors associated with abnormal care path not adapted to emergencies.
Measured: baseline
Evaluate reasons to come to pediatric emergency
Evaluate the reasons why parents of newborns consult pediatric emergency in first intention
Measured: baseline
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.
- First posted11 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion31 Jan 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Laure HERISSE, MD, Principal investigator, Hôpitaux Pédiatriques de Nice CHU-LENVAL
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year Newborn Pediatric Emergencies (NNUP)
- ClinicalTrials.gov ID
- NCT02863627
- Acronym / sponsor ID
- NNUP / 16-HPNCL-04
- Conditions
- Emergencies
- Keywords
- Emergencies, newborn, care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborn Care Pathway | Experimental | Other: Newborn Care Pathwaytwo telephone interviews conducted after the emergency department visit will be used to gather data to meet the objectives of this study. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborn within 28 days included
- Subjects affiliated to Social Security.
- Non-opposition form signed by the two parents.
Key exclusion criteria (2 listed)
- Parental refusal
- non opposition form not signed by the parents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Newborn Care Pathwayconsultation with the pediatric emergency, two telephone interviews to complete Questionnaires with the parents after the emergency department visit | Other | Newborn Care Pathway |
Primary outcome
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.
3 secondary outcomes
Evaluation of abnormal care path
Time frame: baseline
Evaluate reasons to come to pediatric emergency
Time frame: baseline
Evaluate the information received by parents
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 34992122Tran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Laure HERISSE, MD principal investigator
Hôpitaux Pédiatriques de Nice CHU-LENVAL
1 site in 1 country: see every site and its status.
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.