Very Preterm Maturity of InfantPRELIVIANCT06391476
Prematurity at the Limit of Viability
An observational study of Very Preterm Maturity of Infant, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Advancements in perinatal care have significantly improved the survival of extremely premature infants, establishing a viability threshold below 25 weeks' gestational age (GA). However, management at the limit of viability poses ethical and decision-making problems for health-care professionals. Read more about this study
- Who is it for?
- Ages 22 to 25 weeks
- Conditions the study is for
- Very Preterm Maturity of Infant
- What is being tested?
- Study of the evolution of a cohort of children born between 22 and 25 weeks gestational age
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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 22 to 25 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Extremely premature newborn (between 22 and 25 weeks gestational age) treated at the Croix-Rousse hospital
Who may be able to join
- Infants born between 22 and 25 weeks gestational age
- Infants hospitalized at the tertiary care neonatal unit of Croix-Rousse hospital
- Infants born between January 2010 and December 2019
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morbi-mortality and Development at 2 Years in Infants Born at the Limit of Viability
Advancements in perinatal care have significantly improved the survival of extremely premature infants, establishing a viability threshold below 25 weeks' gestational age (GA). However, management at the limit of viability poses ethical and decision-making problems for health-care professionals. They grapple with the delicate balance between potential survival and long-term disabilities.
These decisions, as well as the information given to families, are based on knowledge of the prognosis as assessed by national and international epidemiological studies. Healthcare professionals rely on population-based estimations but face discrepancies in predicting outcomes because there are significant variation depending on perinatal center and country where infants are hospitalized. In the large French epidemiological study, 9,6% of livebirths included were born at 22-25 wks and only 38% survived.
In the neonatology department of the croix rousse, these infants have been actively cared for for many years, which has allowed the development of specific skills that are essential for the proper management of these very high-risk patients. Furthermore, EPIPAGE 2 included data from centers where perinatal management was probably not very active at these extreme ages. It results in worse neonatal outcomes as evaluated at the national level than outcomes data evaluated at the neonatal intensive care unit of Croix-Rousse hospital. Using data from EPIPAGE 2 study for clinical decision could lead to avoid active care at the for some infants at the limit of viability It is needed to obtain complete evaluation of neonatal outcomes of infants hospitalized at the Croix-Rousse hospital, so that clinicians may rely on actualized data related to the practices in their perinatal center. It is also needed to compare outcomes with data from large national and international cohorts, to identify and quantify differences. Data about later neurodevelopment outcomes, at 2 years, are also needed as it can taken in consideration in decision-making process.
- Conditions
- Very Preterm Maturity of Infant
- Being tested
- Study of the evolution of a cohort of children born between 22 and 25 weeks gestational age
- Keywords
- Prematurity, Morbi-mortality, Neurosensory development
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of the evolution of a cohort of children born between 22 and 25 weeks gestational ageOther
- Study of mortality in a cohort of children born between 22 and 25 weeks gestational age
- Study of neonatal morbidity
- Description of postnatal growth
- Description of nutrition and breastfeeding at discharge
- Study of the neurological, respiratory and growth outcome at 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Extremely preterm infants, born between 22 and 25 weeks gestational age | Infant born between 22 and 25 weeks gestational age and hospitalized at the Croix-Rousse Hospital Receives: Other: Study of the evolution of a cohort of children born between 22 and 25 weeks gestational age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Proportion of deaths in a cohort of infants born between 22 - 25 weeks gestational age
Measured: up to 24 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jan 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Preterm Maturity of InfantStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391476
- Sponsor's protocol ID
- CRC_GHN_2024_001
- Acronym
- PRELIVIA
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbi-mortality and Development at 2 Years in Infants Born at the Limit of Viability
- ClinicalTrials.gov ID
- NCT06391476
- Acronym / sponsor ID
- PRELIVIA / CRC_GHN_2024_001
- Conditions
- Very Preterm Maturity of Infant
- Keywords
- Prematurity, Morbi-mortality, Neurosensory development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Apr 2024 (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.
Advancements in perinatal care have significantly improved the survival of extremely premature infants, establishing a viability threshold below 25 weeks' gestational age (GA). However, management at the limit of viability poses ethical and decision-making problems for health-care professionals. They grapple with the delicate balance between potential survival and long-term disabilities.
These decisions, as well as the information given to families, are based on knowledge of the prognosis as assessed by national and international epidemiological studies. Healthcare professionals rely on population-based estimations but face discrepancies in predicting outcomes because there are significant variation depending on perinatal center and country where infants are hospitalized. In the large French epidemiological study, 9,6% of livebirths included were born at 22-25 wks and only 38% survived.
In the neonatology department of the croix rousse, these infants have been actively cared for for many years, which has allowed the development of specific skills that are essential for the proper management of these very high-risk patients. Furthermore, EPIPAGE 2 included data from centers where perinatal management was probably not very active at these extreme ages. It results in worse neonatal outcomes as evaluated at the national level than outcomes data evaluated at the neonatal intensive care unit of Croix-Rousse hospital. Using data from EPIPAGE 2 study for clinical decision could lead to avoid active care at the for some infants at the limit of viability It is needed to obtain complete evaluation of neonatal outcomes of infants hospitalized at the Croix-Rousse hospital, so that clinicians may rely on actualized data related to the practices in their perinatal center. It is also needed to compare outcomes with data from large national and international cohorts, to identify and quantify differences. Data about later neurodevelopment outcomes, at 2 years, are also needed as it can taken in consideration in decision-making process.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extremely preterm infants, born between 22 and 25 weeks gestational age | – | Other: Study of the evolution of a cohort of children born between 22 and 25 weeks gestational ageInfant born between 22 and 25 weeks gestational age and hospitalized at the Croix-Rousse Hospital |
Who may qualify
- Ages
- 22 to 25 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Extremely premature newborn (between 22 and 25 weeks gestational age) treated at the Croix-Rousse hospital
Key inclusion criteria (3 listed)
- Infants born between 22 and 25 weeks gestational age
- Infants hospitalized at the tertiary care neonatal unit of Croix-Rousse hospital
- Infants born between January 2010 and December 2019
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Study of the evolution of a cohort of children born between 22 and 25 weeks gestational age* Study of mortality in a cohort of children born between 22 and 25 weeks gestational age * Study of neonatal morbidity * Description of postnatal growth * Description of nutrition and breastfeeding at discharge * Study of the neurological, respiratory and growth outcome at 2 years. | Other | Extremely preterm infants, born between 22 and 25 weeks gestational age |
Primary outcome
Mortality
Time frame: up to 24 months corrected age
Proportion of deaths in a cohort of infants born between 22 - 25 weeks gestational age
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 30 Apr 2024.
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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 Very Preterm Maturity of Infant, run by Hospices Civils de Lyon 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 30 Apr 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?
Mortality (time frame: up to 24 months corrected age). 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 30 Apr 2024.