Infant, Extremely PrematureNCT03403894
Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea
An observational study of Infant, Extremely Premature, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most cases, a child born before 24 years of age is stillborn, but in about one in three cases, it shows signs of life such as heartbeat, breathing… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Extremely Premature
- What is being tested?
- Asking caregivers in their practice
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2018to 6 Sep 2019
- 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: Child born before 24 weeks of amenorrhea will be study.
Who may be able to join
- Child born before 24 weeks of amenorrhea (term estimated by echographic dating or by the date of the last menstrual period in the absence of ultrasound)
- Inscription in the birth register (so from 15 weeks of amenorrhea)
- Non-opposition of the parents
Who cannot join
- Child transferred to neonatal intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most cases, a child born before 24 years of age is stillborn, but in about one in three cases, it shows signs of life such as heartbeat, breathing, gasps or limb movements.
With these too small children showing signs of life, three attitudes are possible: doing nothing and waiting for this life to stop by themselves, setting up palliative care to ensure the child's comfort, or administering a medication to shorten his or her life. The attitude to have is not univocal and the feeling of the teams confronted with their management is difficult even if the goal of the caregivers is always to act as best as possible.
Read more
The main objective of the study is to describe the clinical state of the child and the practices implemented in the birth room at the Nice University Hospital when children showing signs of life before 24 weeks of amenorrhea are born.
The secondary objective is to describe caregivers' experiences, their experiences of these situations and attitudes towards children and their parents, and to identify ethical dilemmas in these situations.
This study is an observational cohort study including all births of live children before 24 weeks of amenorrhea at Nice University Hospital for 12 months. It consists of two parts: a quantitative study describing the child's condition and caregiving practices, and a qualitative study of caregivers' experiences and the determinants of their attitudes towards the child.
The investigator will coordinate the collection of the data necessary to conduct the quantitative study, and then conduct individual semi-directive interviews with each of the caregivers present at the birth of the child. The qualitative study will be based on the analysis of these interviews.
- Conditions
- Infant, Extremely Premature
- Being tested
- Asking caregivers in their practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asking caregivers in their practiceBehavioural
A questionary is given to caregivers
What is being measured
The primary outcome is the main question the study is designed to answer.
Existence of cardiac activity
Measured: 5 hours
Presence of respiratory movements and/or gasps
Measured: 5 hours
Existence of limb movements
Measured: 5 hours
Place of care
Measured: 5 hours
Identification of the function of the caregiver(s) who performed the care
Measured: 5 hours
Conditions of installation of the child (position, skin-to-skin...)
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start10 Nov 2018
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Extremely PrematureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline MARTIN, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403894
- Sponsor's protocol ID
- 17-AOI-01
- Status last verified
- Nov 2023
- First submitted
- 11 Jan 2018
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea
- ClinicalTrials.gov ID
- NCT03403894
- Acronym / sponsor ID
- 17-AOI-01
- Conditions
- Infant, Extremely Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 19 Jan 2018 (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.
Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most cases, a child born before 24 years of age is stillborn, but in about one in three cases, it shows signs of life such as heartbeat, breathing, gasps or limb movements.
With these too small children showing signs of life, three attitudes are possible: doing nothing and waiting for this life to stop by themselves, setting up palliative care to ensure the child's comfort, or administering a medication to shorten his or her life. The attitude to have is not univocal and the feeling of the teams confronted with their management is difficult even if the goal of the caregivers is always to act as best as possible.
The main objective of the study is to describe the clinical state of the child and the practices implemented in the birth room at the Nice University Hospital when children showing signs of life before 24 weeks of amenorrhea are born.
The secondary objective is to describe caregivers' experiences, their experiences of these situations and attitudes towards children and their parents, and to identify ethical dilemmas in these situations.
This study is an observational cohort study including all births of live children before 24 weeks of amenorrhea at Nice University Hospital for 12 months. It consists of two parts: a quantitative study describing the child's condition and caregiving practices, and a qualitative study of caregivers' experiences and the determinants of their attitudes towards the child.
The investigator will coordinate the collection of the data necessary to conduct the quantitative study, and then conduct individual semi-directive interviews with each of the caregivers present at the birth of the child. The qualitative study will be based on the analysis of these interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Child born before 24 weeks of amenorrhea will be study.
Key inclusion criteria (3 listed)
- Child born before 24 weeks of amenorrhea (term estimated by echographic dating or by the date of the last menstrual period in the absence of ultrasound)
- Inscription in the birth register (so from 15 weeks of amenorrhea)
- Non-opposition of the parents
Key exclusion criteria (1 listed)
- Child transferred to neonatal intensive care unit.
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 |
|---|---|---|
| Asking caregivers in their practiceA questionary is given to caregivers | Behavioural | – |
Primary outcome
Existence of cardiac activity
Time frame: 5 hours
Presence of respiratory movements and/or gasps
Time frame: 5 hours
Existence of limb movements
Time frame: 5 hours
Place of care
Time frame: 5 hours
Identification of the function of the caregiver(s) who performed the care
Time frame: 5 hours
Conditions of installation of the child (position, skin-to-skin...)
Time frame: 5 hours
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 18 Nov 2023.
- 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.
Céline MARTIN principal investigator
Centre Hospitalier Universitaire de Nice
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 Infant, Extremely Premature, run by Centre Hospitalier Universitaire de Nice 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 1 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 18 Nov 2023. 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?
Existence of cardiac activity (time frame: 5 hours). The study lists 6 primary outcomes in all. 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 18 Nov 2023.