At-risk NewbornNURCO-NEONCT05258916
Contribution of a Nurse Consultation in the Follow-up of At-risk Newborn at Maternity Discharged
An observational study of At-risk Newborn, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The postnatal period is a critical phase involving important physiological, psychological and social changes. Pediatric nurses could be a crucial actor in the follow-up of at-risk newborn, in collaboration with other health professionals and contribute to a reduction in pediatric emergency department (PED) visits… Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- At-risk Newborn
- What is being tested?
- Nurse consultation
- Type of treatment
- Surgery or procedure
- How many people
- 1,330 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2022to 11 Jul 2024
- Phase
- Observational
- 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 1 day and older
- All sexes
- Child, Adult, Older adult
Study population: Neonates born and/or hospitalized at a tertiary center, Centre Hospitalier Sud Francilien, Corbeil Essonnes, France defined as follow.
Who may be able to join
- All at-risk newborns addressed to nurse consultation after discharge from maternity hospital.
- All at-risk newborns discharged home after hospitalization at birth in the neonatal medicine department.
Who cannot join
- Newborns discharged with home hospitalization
- Consultation for hearing screening, blood testing or injection (vaccines or palivizumab).
- Newborns referred by pediatrics department, PED or by exterior professionals.
- Non-at-risk newborns hospitalized for other reasons (biological anoxia, early neonatal bacterial infection, transient tachypnea, monitoring)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Contribution of a Nurse Consultation in the Follow-up of At-risk Newborn at Maternity Discharged: 3-year Experience in a Tertiary Center.
The postnatal period is a critical phase involving important physiological, psychological and social changes. Pediatric nurses could be a crucial actor in the follow-up of at-risk newborn, in collaboration with other health professionals and contribute to a reduction in pediatric emergency department (PED) visits and/or hospitalization in first weeks of life. To describe population of at-risk newborns who attended a nurse consultation after discharge from a type 3 maternity hospital and to evaluate the impact of a post-hospitalization nurse consultation for at-risk newborns on PED visits and hospitalizations.
Read the detailed description
The postnatal period is a critical phase involving important physiological, psychological and social changes. In 2013, WHO recommends at least three postnatal contacts on day 3, between days 7 and 14, and six weeks after birth. Despite these recommendations, pediatric emergency department (PED) visits for newborns are constantly increasing. Some studies have shown that most of these visits were related to nonserious diseases, mainly due to a lack of knowledge and information. At the same time, some high-risk newborns have been identified as likely to be admitted to PED and subsequently hospitalized. All these findings highlight the great need for education and parental support by health staff from the time of maternity discharged, particularly when certain high-risk conditions are identified.
In France, guidelines on maternity discharge after childbirth include pediatric nurses as professionals involved in postnatal follow-up. Pediatric nurses could be a crucial actor in the follow-up of at-risk newborn, in collaboration with other health professionals and contribute to a reduction in PED visits and/or hospitalization in first weeks of life.
- Conditions
- At-risk Newborn
- Being tested
- Nurse consultation
- Keywords
- nurse consultation, at-risk newborn, PED visits, PED hospitalizations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse consultationProcedure or surgery
nurse consultation carried out within two weeks after maternity discharged
What is being measured
The primary outcome is the main question the study is designed to answer.
PED visits at 2 weeks
Number and causes of PED visits
Measured: 2 weeks after discharge of maternity hospital
Secondary outcomes (2)
PED visits at 3 months
Number and causes of PED visits
Measured: 3 months after discharge of maternity hospital
Hospitalization
Number and causes of hospitalizations
Measured: 3 months after discharge of maternity hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start11 May 2022
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for At-risk NewbornStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258916
- Sponsor's protocol ID
- 2022/0001
- Acronym
- NURCO-NEO
- Status last verified
- Aug 2024
- First submitted
- 17 Feb 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Contribution of a Nurse Consultation in the Follow-up of At-risk Newborn at Maternity Discharged: 3-year Experience in a Tertiary Center.
- ClinicalTrials.gov ID
- NCT05258916
- Acronym / sponsor ID
- NURCO-NEO / 2022/0001
- Conditions
- At-risk Newborn
- Keywords
- nurse consultation, at-risk newborn, PED visits, PED hospitalizations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,330 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 28 Feb 2022 (actual)
- 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.
The postnatal period is a critical phase involving important physiological, psychological and social changes. Pediatric nurses could be a crucial actor in the follow-up of at-risk newborn, in collaboration with other health professionals and contribute to a reduction in pediatric emergency department (PED) visits and/or hospitalization in first weeks of life. To describe population of at-risk newborns who attended a nurse consultation after discharge from a type 3 maternity hospital and to evaluate the impact of a post-hospitalization nurse consultation for at-risk newborns on PED visits and hospitalizations.
Detailed description
The postnatal period is a critical phase involving important physiological, psychological and social changes. In 2013, WHO recommends at least three postnatal contacts on day 3, between days 7 and 14, and six weeks after birth. Despite these recommendations, pediatric emergency department (PED) visits for newborns are constantly increasing. Some studies have shown that most of these visits were related to nonserious diseases, mainly due to a lack of knowledge and information. At the same time, some high-risk newborns have been identified as likely to be admitted to PED and subsequently hospitalized. All these findings highlight the great need for education and parental support by health staff from the time of maternity discharged, particularly when certain high-risk conditions are identified.
In France, guidelines on maternity discharge after childbirth include pediatric nurses as professionals involved in postnatal follow-up. Pediatric nurses could be a crucial actor in the follow-up of at-risk newborn, in collaboration with other health professionals and contribute to a reduction in PED visits and/or hospitalization in first weeks of life.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Neonates born and/or hospitalized at a tertiary center, Centre Hospitalier Sud Francilien, Corbeil Essonnes, France defined as follow.
Key inclusion criteria (2 listed)
- All at-risk newborns addressed to nurse consultation after discharge from maternity hospital.
- All at-risk newborns discharged home after hospitalization at birth in the neonatal medicine department.
Key exclusion criteria (4 listed)
- Newborns discharged with home hospitalization
- Consultation for hearing screening, blood testing or injection (vaccines or palivizumab).
- Newborns referred by pediatrics department, PED or by exterior professionals.
- Non-at-risk newborns hospitalized for other reasons (biological anoxia, early neonatal bacterial infection, transient tachypnea, monitoring)
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 |
|---|---|---|
| Nurse consultationnurse consultation carried out within two weeks after maternity discharged | Procedure or surgery | – |
Primary outcome
PED visits at 2 weeks
Time frame: 2 weeks after discharge of maternity hospital
Number and causes of PED visits
2 secondary outcomes
PED visits at 3 months
Time frame: 3 months after discharge of maternity hospital
Hospitalization
Time frame: 3 months after discharge of maternity hospital
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 15 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for At-risk Newborn
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
Not yet recruiting
Reduce All Avoidable Cancer-promoting Exposures in Individuals at High Genetic Risk of Cancer Carrying a Constitutional Variant of the TP53 Gene
Adult Carriers of a Pathogenic or Probably Pathogenic (Class 4 and 5) Germline Variation in the TP53 Gene
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
RecruitingPhase 3
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Thrombocytopenia, Neonatal Alloimmune
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of At-risk Newborn, run by Centre Hospitalier Sud Francilien 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 2 inclusion and 4 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 15 Aug 2024. 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?
PED visits at 2 weeks (time frame: 2 weeks after discharge of maternity hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.