NeonatologyNCT03046602
Parental Real-life Experience During the Neonatal Transfer
An observational study of Neonatology, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for parents.This anxiety could have repercussion on parents adaptation on their new environment, on parent's role and also on their relaional interaction with the baby. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatology
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2016to 31 Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Every new born child transfered to St Joseph neonatology service
Who may be able to join
- new born child transfered to St Joseph neonatology service
- Having stayed at least five days Intensive Care Unit
- Regardless of the term
- have to stay at least five days in neonatology
Who cannot join
- Non francophones parents
- Duration of predictable hospitalization of less than 5 days
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Parental Real-life Experience During the Neonatal Transfer From Intensive Care Unit to Maternity Service of St Joseph Hospital
The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for parents.This anxiety could have repercussion on parents adaptation on their new environment, on parent's role and also on their relaional interaction with the baby. As StJoseph hospital receives an important number of premature babies, the neonatology service aim to evaluate the real life experience of mothers during the transfer to set up improvement axes with hospital departments upstream.
- Conditions
- Neonatology
What is being measured
The primary outcome is the main question the study is designed to answer.
mother's real life experience assessment during the transfer of new born child from intensive care unit to neonatology
Measured: day 3 to 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start7 Mar 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonatologyStudies 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
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène BEAUSSIER, Pharm-D, Study director, CRC- GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046602
- Sponsor's protocol ID
- TransfereNN
- Status last verified
- Aug 2018
- First submitted
- 5 Feb 2017
- Last updated
- 10 Aug 2018
- 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 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Real-life Experience During the Neonatal Transfer From Intensive Care Unit to Maternity Service of St Joseph Hospital
- ClinicalTrials.gov ID
- NCT03046602
- Acronym / sponsor ID
- TransfereNN
- Conditions
- Neonatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 8 Feb 2017 (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.
The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for parents.This anxiety could have repercussion on parents adaptation on their new environment, on parent's role and also on their relaional interaction with the baby. As StJoseph hospital receives an important number of premature babies, the neonatology service aim to evaluate the real life experience of mothers during the transfer to set up improvement axes with hospital departments upstream.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Every new born child transfered to St Joseph neonatology service
Key inclusion criteria (4 listed)
- new born child transfered to St Joseph neonatology service
- Having stayed at least five days Intensive Care Unit
- Regardless of the term
- have to stay at least five days in neonatology
Key exclusion criteria (2 listed)
- Non francophones parents
- Duration of predictable hospitalization of less than 5 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mother's real life experience assessment during the transfer of new born child from intensive care unit to neonatology
Time frame: day 3 to 5
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 10 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Neonatology
RecruitingObservational study
Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
Neonatal Infection
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
Not yet recruitingPhase 2/3
Dexmedetomidine for Invasive Ventilation In the NEOnate
Invasive Ventilation, Infant Pain
Recruiting
EXTERNAL NEGATIVE PRESSURE DURING LISA
Neonatology
Recruiting
NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn Infants
Neonatal Intensive Care
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.
Hélène BEAUSSIER, Pharm-D study director
CRC- GHPSJ
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 Neonatology, run by Fondation Hôpital Saint-Joseph 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 4 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 10 Aug 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?
mother's real life experience assessment during the transfer of new born child from intensive care unit to neonatology (time frame: day 3 to 5). 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 10 Aug 2018.