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Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants (OutbornTRANSF)

26 maja 2026 zaktualizowane przez: Assistance Publique - Hôpitaux de Paris

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.

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

627

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Peter JONES, MB BChir PhD
  • Numer telefonu: +33 06 12 34 76 82
  • E-mail: peter.jones@aphp.fr

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Outborn Infants
Extremely preterm infants born at 23+0-28+6 weeks' gestation in maternity units without on-site neonatal intensive care.
Inny: Usual Care
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Survival without major neurodevelopmental disability
Ramy czasowe: 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.
at 2 years corrected gestational age

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mortality
Ramy czasowe: From inclusion (birth) up to one year of corrected age
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)
From inclusion (birth) up to one year of corrected age
Severe neurological sequelae
Ramy czasowe: At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)
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
At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)
Severe morbidity
Ramy czasowe: At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)

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
At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)
Hemodynamic, respiratory, and thermal parameters
Ramy czasowe: At birth
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.
At birth
Time from birth to arrival in intensive care
Ramy czasowe: At birth
Time from birth to arrival in intensive care and frequency of delay under 60 minutes
At birth
Prognosis
Ramy czasowe: At birth
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).
At birth
Intubations
Ramy czasowe: At birth
Frequency of intubations, surfactant administration, and inotropic drugs administration
At birth
Cerebral palsy
Ramy czasowe: 2 years of corrected age
Frequency of cerebral palsy as reported by paediatrician at 2 years of corrected age
2 years of corrected age
Major neurodevelopmental disability
Ramy czasowe: 2 years of corrected age
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)
2 years of corrected age
Healthcare resource use
Ramy czasowe: 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.

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).
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
Ramy czasowe: One month after discharge
Average score of parental experience measured by a 0-10 numeric scale (10 indicating best experience).
One month after discharge
Parental experience 2
Ramy czasowe: One month after discharge
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
One month after discharge
Parents' mental health 1
Ramy czasowe: One month after hospital discharge and at 6, 12, 18, and 24 months of corrected age
EPDS score > 12 between 0-12 months of infants indicating high risk of postpartum depression
One month after hospital discharge and at 6, 12, 18, and 24 months of corrected age
Parent's mental health 2
Ramy czasowe: One month after hospital discharge and at 6, 12, 18 and 24 months of corrected age
PHQ-9 score ≥ 10 over 12 months postpartum indicating moderate to severe depression in adults
One month after hospital discharge and at 6, 12, 18 and 24 months of corrected age
Parents' quality of life
Ramy czasowe: One month after hospital discharge and at 6, 12, 18, and 24 months of corrected age.
Quality of life measured by WHOQOL-Bref questionnaire. Average scoreof each sub scale will be used for comparisons
One month after hospital discharge and at 6, 12, 18, and 24 months of corrected age.
Cost-effectiveness 1
Ramy czasowe: From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months).
Incremental cost-utility ratio in terms of cost per QALY gained (for parents)
From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months).
Cost effectiveness 2
Ramy czasowe: From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months)
Incremental cost-effectiveness ratio in terms of cost per life year gained (for infants)
From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months)
Economic impact 1
Ramy czasowe: 5 years after hypothetical generalization
The economic impact assessed by estimating the costs and health gains (deaths/sequelae avoided) associated with generalising NNT antenatal positionning
5 years after hypothetical generalization
Economic impact 2
Ramy czasowe: 5 years after hypothetical generalization
The economic impact assessed by estimating the health gains (deaths/sequelae avoided) associated with generalising NNT antenatal positioning
5 years after hypothetical generalization
Social inequalities
Ramy czasowe: From inclusion up to 5 months after birth
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
From inclusion up to 5 months after birth
Regional inequalities
Ramy czasowe: From inclusion up to 5 months after birth
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
From inclusion up to 5 months after birth
NNT local organization
Ramy czasowe: From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months).
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
From the first enrollment to the end of follow-up for the last enrolled child (4 years and 4 months).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Assistance Publique - Hôpitaux de Paris

Śledczy

  • Główny śledczy: Peter JONES, MB BChir PhD, SAMU du Val de l'Oise

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 września 2030

Ukończenie studiów (Szacowany)

1 września 2030

Daty rejestracji na studia

Pierwszy przesłany

14 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 maja 2026

Pierwszy wysłany (Rzeczywisty)

12 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • APHP251257
  • PREPS-24-0182 (Inny numer grantu/finansowania: French Ministry of Health)
  • 2025-A02162-47 (Inny identyfikator: ID-RCB)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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