Prematurity ComplicationsOutbornTRANSFNCT07580859
Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants
An observational study of Prematurity Complications and Neurodevelopment Outcome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births (delivered in maternity units with on-site neonatal intensive care). Read more about this study
- Who is it for?
- Ages 0 days to 28 months
- Conditions the study is for
- Prematurity Complications, Neurodevelopment Outcome, Prematurity
- How many people
- 627 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Sep 2030
- How long will I take part?
- 28 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 28 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants of 23+0-28+6 weeks of gestation born outside a level 3 maternity (level 1/2a/2b - without NICU) in Mainland France, and alive at the moment of arrival of the NNT.
Eligible for inclusion are infants for whom an antenatal call to the emergency medical service (SAMU) was initiated due to prematurity (imminent delivery and infant alive at the time of the call) and who:
- Were born outside a level 3 maternity hospital (outborn birth) in mainland France
- Have a gestational age at birth between of 23+0 - 28+6
- Have parents who speak and understand French (required for telephone follow-up) To assess parent-related outcomes, parents will also be included in the study if their infant is eligible and if they have not objected to participation.
Infants will not be included if one or both parents are unable to speak and understand French, if at least one of the parents is opposed to inclusion, if they had lethal congenital malformations or if they were born outside hospital (accidental premature home births).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
SAMU de Pontoise, Hopital Novo
Pontoise, 95300
Guillaume POIRIE, MD, 06 30 61 08 13 ext. +33, guillaume.poirie@ght-novo.fr
About this study
Official title: A Prospective French National Study of the Impact of Antenatal Versus Postnatal Positioning of a Neonatal Transport Team on Survival and Severe Neurodevelopmental Delay at Two Years in Outborn 23-28 Weeks Infants : outbornTRANSFER Study Protocol
The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births (delivered in maternity units with on-site neonatal intensive care).
This project aims to assess the effect of the neonatal transport team (NNT) antenatal versus postnatal positioning on outborn survival without major neurodevelopmental sequelae at two years of corrected age (CA). A national, multicenter, observational cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation in mainland France for which a NNT is deployed and who are alive at the moment of arrival of the NNT. 627 infants born outborn and their families will be followed until the child reaches two years of corrected age.
Read more
Study will examine quality of neonatal resuscitation, stability during transport, neonatal morbidity, parental mental health and quality of life, medico-economic outcomes for both families and the healthcare system and regional provision of care.
If parents agree to participate after receiving appropriate information, hospital records will be used to collect maternal and neonatal characteristics as well as morbidity data. Telephone follow-up will be conducted one month after discharge and then every six months until 2 years of corrected age (CA). Neurodevelopment at 2 years of corrected age will be assessed using the ASQ-3, completed by the parents.
Through a detailed understanding of the processes of resuscitation, stabilization and transport, our goal is to reduce unnecessary deaths and disability for children and families, including long-term economic costs. The recommendations for the care of outborn preterm infants and for the optimization of NNT resources will be developed.
Read the detailed description
Numerous studies have shown that outborn preterm infants born at 23+0-28+6 weeks' gestation in maternity units without on-site neonatal intensive care unit (NICU) have higher rates of mortality and severe disability compared with inborn infants (delivered in maternity units with on-site neonatal intensive care). These differences are partly explained by variations in maternal characteristics, as well as in resuscitation and transport conditions. To date, no study has evaluated the impact of the presence of a neonatal transport team (NNT) beyond short-term transport-related complications.
The primary objective is to assess the effect of the antenatal NNT positioning, compared with postnatal NNT positioning, on survival without major neurodevelopmental sequelae at two years of corrected age (CA) in outborn preterm infants born at 23+0-28+6 weeks' gestation.
Secondary objectives will evaluate the effects on morbidity and mortality and neonatal health, medical interventions and the infant's stability during transport, healthcare utilization, as well as parents' experiences, mental health, and quality of life throughout follow-up. Cost-effectiveness and budget impact will also be examined, along with social and geographic inequalities in morbidity and mortality at two years. Barriers to and facilitators of organizing pediatric transport for outborn preterm infants will be identified in collaboration with neonatal transport teams.
The population included in the OutbornTRANSFER study are extremely preterm newborns born in mainland France in a maternity unit without on-site neonatal intensive care, and managed by one of the 32 specialized neonatal transport teams.
A national, multicenter, observational, longitudinal cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation for which a NNT is deployed and who are alive at the moment of arrival of the NNT. Preterm outborn infants and their families will be followed until the child reaches two years of corrected age.
An economic evaluation will also be conducted, as well as a mixed-method study among medical professionals from participating NNT.
If the infant survives and is transported to a neonatal intensive care unit, the NNT investigator will inform the parents about the study and invite them to participate. If the investigator is unable to meet the parents, an information leaflet and a flyer (including a unique identification number and a QR code) will be placed in the child's health record booklet, enabling parents to access a study-specific electronic data collection application and to provide their non-opposition online.
Data on birth, initial care, transport, and timing of NNT positioning will be collected using the NNT data transportation sheet dedicated to the study, completed by the NNT study investigator.
The NNT study investigator will obtain hospitalization discharge reports, which include relevant medical history, pregnancy course, birth details, and the infant's hospital stay, with particular focus on severe conditions relevant to the cohort's outcome measures.
One month after hospital discharge, a research assistant will contact both parents to re-explain the telephone follow-up procedures, including the collection of data on parental experiences during hospitalization, parental mental health, and health-related quality of life since discharge. Subsequent telephone assessments will be conducted at 6, 12, 18, and 24 months corrected age.
A collaboration will be established with the Vulnerable Children Network (Réseau de Suivi des Enfants Vulnérables - RSEV), which organizes and performs auditory, ophthalmological, psychological, and physical assessments of premature infants, including the Ages and stages questionnaire (ASQ). One month prior to the infant's 24-month corrected age visit, the research assistant will contact the parents to present the ASQ-3 and encourage completion during the RSEV pediatric visit or directly via the study web app if they do not participate in the network follow-up. The research assistant will then collect the reports from the RSEV pediatrician for the 24-month visit.
The investigators will link the cohort data with data from national health data system (SNDS - Système National des Données de Santé) to evaluate healthcare consumptions by the mother (and subsequently the premature infant) during pregnancy and up to 24 months corrected age of the infant.
- Being tested
- Usual Care
- Keywords
- Prematurity, Outborn, Transport, Mortality, Cohort study, Neurodevelopment
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Children will be followed using each participating center's usual practices. Parental experiences of hospitalization, parental mental health and health-related quality of life since discharge will be assessed by telephone at 6, 12, 18, and 24 months of corrected age.
| Study group | Role | What they receive |
|---|---|---|
| Outborn Infants | Extremely preterm infants born at 23+0-28+6 weeks' gestation in maternity units without on-site neonatal intensive care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without major neurodevelopmental disability
The primary outcome is a binary composite criteria based on three elements: 1) Survival ; 2) Absence of severe or moderate neuromotor or sensory disability at 2 yearsAC (defined as cerebral palsy with levels 2 to 5 of the gross motor classification system (GMFCS), blindness, or unilateral or bilateral deafness), allowing the application of the ASQ-3; 3) Absence of neurodevelopmental sequelae at 2 yearsAC assessed by the Age and Stage Questionnaire version 3 (the ASQ-3.). It is a parental questionnaire (completed by one or both parents together), based on their observations of their child's development. A developmental delay is defined as a score of < -2SD in one of the five subdomains of the questionnaire.
Measured: at 2 years corrected gestational age
Secondary outcomes (22)
Mortality
Number of death during the first year (infant), the first 28 days (neonatal), the first week (early neonatal) and during hospital stay (in-hospital mortality)
Measured: From inclusion (birth) up to one year of corrected age
Severe neurological sequelae
Binary composite criteria based on the absence of periventricular leukomalacia (cavities in the periventricular white matter during transfontanellar ultrasound) or stage 3 intraventricular hemorrhage (IVH) with associated ventricular dilatation or stage 4 IVH associated with hemorrhagic lesions in the adjacent parenchyma during transfontanellar ultrasound
Measured: At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)
Severe morbidity
Composite morbidity criteria defined by the absence of :
- Periventricular leukomalacia
- Stage 3-4 IVH
- Severe bronchopulmonary dysplasia (BPD) defined as requiring oxygen or ventilatory support (non-invasive or endotracheal) at 36 weeks of theoretical gestational age
- Severe necrotizing enterocolitis (NEC) corresponding to types 2 and 3 of the modified Bell classification
- Severe retinopathy of prematurity (ROP) stage 3 or higher according to the international classification of ROP
Measured: At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)
Hemodynamic, respiratory, and thermal parameters
Average change in hemodynamic (BP, HR), respiratory (RR, SaO₂, FiO₂) and thermal (skin sensor temperature) parameters between departure from the maternity ward and arrival in intensive care.
Measured: At birth
Time from birth to arrival in intensive care
Time from birth to arrival in intensive care and frequency of delay under 60 minutes
Measured: At birth
Prognosis
Prognosis based on the TRIPS II score (Transport Risk index of Physiologic Stability, version II, comprising four weighted items: temperature, blood pressure, respiratory support, and response to stimuli).
Measured: At birth
Intubations
Frequency of intubations, surfactant administration, and inotropic drugs administration
Measured: At birth
Cerebral palsy
Frequency of cerebral palsy as reported by paediatrician at 2 years of corrected age
Measured: 2 years of corrected age
Major neurodevelopmental disability
Frequency of the binary composite criteria combining : 1/Survival ; 2/Absence of severe or moderate neuromotor or sensory disability at 2 y.CA defined as cerebral palsy with levels 2 to 5 of the gross motor classification system (GMFCS), blindness, or unilateral or bilateral deafness)
Measured: 2 years of corrected age
Healthcare resource use
Frequency of pediatric consultations (pediatrician or general practitioner); hospitalizations since discharge from neonatal care; emergency room visits without hospitalization; specialized consultations and additional imaging tests.
Frequency of non-reimbursed care (psychologist, psychomotor therapist) and use of care facilities (CAMPS, specialized centers) and MDPH procedures (requests for financial assistance, priority cards, or parking permits).
Measured: From birth to the end of follow-up (2 years corrected gestational age), specifically one month after the end of the initial period of hospitalisation, thereafter 6, 12, 18 and 24 months of corrected gestational age.
Parental experience 1
Average score of parental experience measured by a 0-10 numeric scale (10 indicating best experience).
Measured: One month after discharge
Parental experience 2
Frequency of acute and post-traumatic stress measured by the IES-R scale with normal score <24, moderate risk between 24-32 and severe risk if≥ 33
Measured: One month after discharge
Parents' mental health 1
EPDS score > 12 between 0-12 months of infants indicating high risk of postpartum depression
Measured: One month after hospital discharge and at 6, 12, 18, and 24 months of corrected age
Parent's mental health 2
PHQ-9 score ≥ 10 over 12 months postpartum indicating moderate to severe depression in adults
Measured: One month after hospital discharge and at 6, 12, 18 and 24 months of corrected age
Parents' quality of life
Quality of life measured by WHOQOL-Bref questionnaire. Average scoreof each sub scale will be used for comparisons
Measured: One month after hospital discharge and at 6, 12, 18, and 24 months of corrected age.
Cost-effectiveness 1
Incremental cost-utility ratio in terms of cost per QALY gained (for parents)
Measured: From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months).
Cost effectiveness 2
Incremental cost-effectiveness ratio in terms of cost per life year gained (for infants)
Measured: From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months)
Economic impact 1
The economic impact assessed by estimating the costs and health gains (deaths/sequelae avoided) associated with generalising NNT antenatal positionning
Measured: 5 years after hypothetical generalization
Economic impact 2
The economic impact assessed by estimating the health gains (deaths/sequelae avoided) associated with generalising NNT antenatal positioning
Measured: 5 years after hypothetical generalization
Social inequalities
All outcomes (except economic outcomes) cross-analyzed with parental social factors (age, level of education, family composition, employment status, financial comfort, socio-professional category, country of birth, language spoken at home, social security and supplementary health insurance coverage) will be studied
Measured: From inclusion up to 5 months after birth
Regional inequalities
All outcomes (except economic outcomes) cross-analyzed with parental spatial factors (department of residence, APL, distance from home to place of delivery, distance from home to level 3 maternity unit) will be studied
Measured: From inclusion up to 5 months after birth
NNT local organization
Analysis of transcription to identify obstacles and drivers in the local organization of care for premature infants. Description of the characteristics of the professionals participating in the qualitative study and of each participating NNT
Measured: From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity ComplicationsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 627 participants (estimated)
- Target duration
- 28 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter JONES, MB BChir PhD, Principal investigator, SAMU du Val de l'Oise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580859
- Sponsor's protocol ID
- APHP251257
- Other IDs
- PREPS-24-0182, 2025-A02162-47
- Acronym
- OutbornTRANSF
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 28 May 2026
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective French National Study of the Impact of Antenatal Versus Postnatal Positioning of a Neonatal Transport Team on Survival and Severe Neurodevelopmental Delay at Two Years in Outborn 23-28 Weeks Infants : outbornTRANSFER Study Protocol
- ClinicalTrials.gov ID
- NCT07580859
- Acronym / sponsor ID
- OutbornTRANSF / APHP251257
- Keywords
- Prematurity, Outborn, Transport, Mortality, Cohort study, Neurodevelopment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 627 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 12 May 2026 (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 extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births (delivered in maternity units with on-site neonatal intensive care).
This project aims to assess the effect of the neonatal transport team (NNT) antenatal versus postnatal positioning on outborn survival without major neurodevelopmental sequelae at two years of corrected age (CA). A national, multicenter, observational cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation in mainland France for which a NNT is deployed and who are alive at the moment of arrival of the NNT. 627 infants born outborn and their families will be followed until the child reaches two years of corrected age.
Study will examine quality of neonatal resuscitation, stability during transport, neonatal morbidity, parental mental health and quality of life, medico-economic outcomes for both families and the healthcare system and regional provision of care.
If parents agree to participate after receiving appropriate information, hospital records will be used to collect maternal and neonatal characteristics as well as morbidity data. Telephone follow-up will be conducted one month after discharge and then every six months until 2 years of corrected age (CA). Neurodevelopment at 2 years of corrected age will be assessed using the ASQ-3, completed by the parents.
Through a detailed understanding of the processes of resuscitation, stabilization and transport, our goal is to reduce unnecessary deaths and disability for children and families, including long-term economic costs. The recommendations for the care of outborn preterm infants and for the optimization of NNT resources will be developed.
Detailed description
Numerous studies have shown that outborn preterm infants born at 23+0-28+6 weeks' gestation in maternity units without on-site neonatal intensive care unit (NICU) have higher rates of mortality and severe disability compared with inborn infants (delivered in maternity units with on-site neonatal intensive care). These differences are partly explained by variations in maternal characteristics, as well as in resuscitation and transport conditions. To date, no study has evaluated the impact of the presence of a neonatal transport team (NNT) beyond short-term transport-related complications.
The primary objective is to assess the effect of the antenatal NNT positioning, compared with postnatal NNT positioning, on survival without major neurodevelopmental sequelae at two years of corrected age (CA) in outborn preterm infants born at 23+0-28+6 weeks' gestation.
Secondary objectives will evaluate the effects on morbidity and mortality and neonatal health, medical interventions and the infant's stability during transport, healthcare utilization, as well as parents' experiences, mental health, and quality of life throughout follow-up. Cost-effectiveness and budget impact will also be examined, along with social and geographic inequalities in morbidity and mortality at two years. Barriers to and facilitators of organizing pediatric transport for outborn preterm infants will be identified in collaboration with neonatal transport teams.
The population included in the OutbornTRANSFER study are extremely preterm newborns born in mainland France in a maternity unit without on-site neonatal intensive care, and managed by one of the 32 specialized neonatal transport teams.
A national, multicenter, observational, longitudinal cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation for which a NNT is deployed and who are alive at the moment of arrival of the NNT. Preterm outborn infants and their families will be followed until the child reaches two years of corrected age.
An economic evaluation will also be conducted, as well as a mixed-method study among medical professionals from participating NNT.
If the infant survives and is transported to a neonatal intensive care unit, the NNT investigator will inform the parents about the study and invite them to participate. If the investigator is unable to meet the parents, an information leaflet and a flyer (including a unique identification number and a QR code) will be placed in the child's health record booklet, enabling parents to access a study-specific electronic data collection application and to provide their non-opposition online.
Data on birth, initial care, transport, and timing of NNT positioning will be collected using the NNT data transportation sheet dedicated to the study, completed by the NNT study investigator.
The NNT study investigator will obtain hospitalization discharge reports, which include relevant medical history, pregnancy course, birth details, and the infant's hospital stay, with particular focus on severe conditions relevant to the cohort's outcome measures.
One month after hospital discharge, a research assistant will contact both parents to re-explain the telephone follow-up procedures, including the collection of data on parental experiences during hospitalization, parental mental health, and health-related quality of life since discharge. Subsequent telephone assessments will be conducted at 6, 12, 18, and 24 months corrected age.
A collaboration will be established with the Vulnerable Children Network (Réseau de Suivi des Enfants Vulnérables - RSEV), which organizes and performs auditory, ophthalmological, psychological, and physical assessments of premature infants, including the Ages and stages questionnaire (ASQ). One month prior to the infant's 24-month corrected age visit, the research assistant will contact the parents to present the ASQ-3 and encourage completion during the RSEV pediatric visit or directly via the study web app if they do not participate in the network follow-up. The research assistant will then collect the reports from the RSEV pediatrician for the 24-month visit.
The investigators will link the cohort data with data from national health data system (SNDS - Système National des Données de Santé) to evaluate healthcare consumptions by the mother (and subsequently the premature infant) during pregnancy and up to 24 months corrected age of the infant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outborn Infants | – | Other: Usual CareExtremely preterm infants born at 23+0-28+6 weeks' gestation in maternity units without on-site neonatal intensive care. |
Who may qualify
- Ages
- 0 days to 28 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants of 23+0-28+6 weeks of gestation born outside a level 3 maternity (level 1/2a/2b - without NICU) in Mainland France, and alive at the moment of arrival of the NNT.
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 |
|---|---|---|
| Usual CareChildren will be followed using each participating center's usual practices. Parental experiences of hospitalization, parental mental health and health-related quality of life since discharge will be assessed by telephone at 6, 12, 18, and 24 months of corrected age. | Other | Outborn Infants |
Primary outcome
Survival without major neurodevelopmental disability
Time frame: at 2 years corrected gestational age
The primary outcome is a binary composite criteria based on three elements: 1) Survival ; 2) Absence of severe or moderate neuromotor or sensory disability at 2 yearsAC (defined as cerebral palsy with levels 2 to 5 of the gross motor classification system (GMFCS), blindness, or unilateral or bilateral deafness), allowing the application of the ASQ-3; 3) Absence of neurodevelopmental sequelae at 2 yearsAC assessed by the Age and Stage Questionnaire version 3 (the ASQ-3.). It is a parental questionnaire (completed by one or both parents together), based on their observations of their child's development. A developmental delay is defined as a score of < -2SD in one of the five subdomains of the questionnaire.
22 secondary outcomes
Mortality
Time frame: From inclusion (birth) up to one year of corrected age
Severe neurological sequelae
Time frame: At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)
Severe morbidity
Time frame: At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)
Hemodynamic, respiratory, and thermal parameters
Time frame: At birth
Time from birth to arrival in intensive care
Time frame: At birth
Prognosis
Time frame: At birth
Intubations
Time frame: At birth
Cerebral palsy
Time frame: 2 years of corrected age
Major neurodevelopmental disability
Time frame: 2 years of corrected age
Healthcare resource use
Time frame: From birth to the end of follow-up (2 years corrected gestational age), specifically one month after the end of the initial period of hospitalisation, thereafter 6, 12, 18 and 24 months of corrected gestational age.
Parental experience 1
Time frame: One month after discharge
Parental experience 2
Time frame: One month after discharge
Parents' mental health 1
Time frame: One month after hospital discharge and at 6, 12, 18, and 24 months of corrected age
Parent's mental health 2
Time frame: One month after hospital discharge and at 6, 12, 18 and 24 months of corrected age
Parents' quality of life
Time frame: One month after hospital discharge and at 6, 12, 18, and 24 months of corrected age.
Cost-effectiveness 1
Time frame: From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months).
Cost effectiveness 2
Time frame: From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months)
Economic impact 1
Time frame: 5 years after hypothetical generalization
Economic impact 2
Time frame: 5 years after hypothetical generalization
Social inequalities
Time frame: From inclusion up to 5 months after birth
Regional inequalities
Time frame: From inclusion up to 5 months after birth
NNT local organization
Time frame: From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- 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.
Peter JONES, MB BChir PhD principal investigator
SAMU du Val de l'Oise
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 Prematurity Complications and Neurodevelopment Outcome, run by Assistance Publique - Hôpitaux de Paris 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?
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: opening soon, as of the sponsor's last update on 28 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter JONES, MB BChir PhD (06 12 34 76 82 ext. +33, peter.jones@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without major neurodevelopmental disability (time frame: at 2 years corrected gestational 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 28 May 2026.