Premature Between 32 and 36 Weeks of AmenorrhoeaPREM3236NCT06078618
Place of Birth and Neonatal Health in Cases of Premature Birth Between 32 and 36 Weeks of Amenorrhoea
An observational study of Premature Between 32 and 36 Weeks of Amenorrhoea, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental sequelae compared with full-term newborns. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Premature Between 32 and 36 Weeks of Amenorrhoea
- How many people
- 240,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 31 Mar 2023
- 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 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective cohort based on an extraction from the National Health Data System (SNDS) and including all pregnant women giving birth between 32 and 36 completed weeks of amenorrhoea, between 1st January 2015 and 31st December 2020 in France and their newborn babies (live or stillborn).
Who may be able to join
- All mothers and their newborn babies (live or stillborn) who had a delivery stay between 32 and 36 days of age recorded in the PMSI between 01/01/2015 and 31/12/2020.
Who cannot join
- Births in very small maternity units
- Births in hospitals without an obstetrics unit
- Births outside hospitals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Place of Birth and Neonatal Health in Cases of Preterm Birth Between 32 and 36 Weeks of Amenorrhoea: a National Population-based Study
Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental sequelae compared with full-term newborns.
In the case of preterm birth, optimal antenatal, birth and postnatal management is necessary to prevent neonatal complications and mitigate longer-term consequences. However, we lack knowledge about the management of this at-risk population and the factors influencing their health.
This knowledge is needed in the current context of unfavourable trends in neonatal health. Over the last ten years, neonatal and infant mortality has stagnated in France, with France falling behind other European countries. According to the latest European report, France ranks 22nd out of 33 countries. The causes of this stagnation are not well known, but many hypotheses have been put forward, including sub-optimal organisation of care.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cohort | Mothers and their newborn babies (live or stillborn) who were delivered between 32 and 36 weeks' gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Mortality (stillbirths, neonatal mortality before 28 days, hospital mortality)
Measured: up to 28 days after birth
Neonatal morbidity rate
Neonatal morbidity. Composite indicator of neonatal morbidity defined by 18 ICD 10 and/or CCAM diagnostic codes and including the following sub-categories: respiratory, infectious, neurological, metabolic pathologies and obstetric trauma.
Measured: up to 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Jan 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Between 32 and 36 Weeks of AmenorrhoeaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 240,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078618
- Sponsor's protocol ID
- DESPLANCHES APJ 2021
- Acronym
- PREM3236
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of Birth and Neonatal Health in Cases of Preterm Birth Between 32 and 36 Weeks of Amenorrhoea: a National Population-based Study
- ClinicalTrials.gov ID
- NCT06078618
- Acronym / sponsor ID
- PREM3236 / DESPLANCHES APJ 2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 12 Oct 2023 (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.
Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental sequelae compared with full-term newborns.
In the case of preterm birth, optimal antenatal, birth and postnatal management is necessary to prevent neonatal complications and mitigate longer-term consequences. However, we lack knowledge about the management of this at-risk population and the factors influencing their health.
This knowledge is needed in the current context of unfavourable trends in neonatal health. Over the last ten years, neonatal and infant mortality has stagnated in France, with France falling behind other European countries. According to the latest European report, France ranks 22nd out of 33 countries. The causes of this stagnation are not well known, but many hypotheses have been put forward, including sub-optimal organisation of care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | –Mothers and their newborn babies (live or stillborn) who were delivered between 32 and 36 weeks' gestation |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective cohort based on an extraction from the National Health Data System (SNDS) and including all pregnant women giving birth between 32 and 36 completed weeks of amenorrhoea, between 1st January 2015 and 31st December 2020 in France and their newborn babies (live or stillborn).
Key inclusion criteria (1 listed)
- All mothers and their newborn babies (live or stillborn) who had a delivery stay between 32 and 36 days of age recorded in the PMSI between 01/01/2015 and 31/12/2020.
Key exclusion criteria (3 listed)
- Births in very small maternity units
- Births in hospitals without an obstetrics unit
- Births outside hospitals.
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
Mortality rate
Time frame: up to 28 days after birth
Mortality (stillbirths, neonatal mortality before 28 days, hospital mortality)
Neonatal morbidity rate
Time frame: up to 28 days after birth
Neonatal morbidity. Composite indicator of neonatal morbidity defined by 18 ICD 10 and/or CCAM diagnostic codes and including the following sub-categories: respiratory, infectious, neurological, metabolic pathologies and obstetric trauma.
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 12 Oct 2023.
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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.
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 Premature Between 32 and 36 Weeks of Amenorrhoea, run by Centre Hospitalier Universitaire Dijon 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 1 inclusion and 3 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 12 Oct 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?
Mortality rate (time frame: up to 28 days after birth). The study lists 2 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 12 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.