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

26. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Pozorovací

Zápis (Odhadovaný)

627

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

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

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Outborn Infants
Extremely preterm infants born at 23+0-28+6 weeks' gestation in maternity units without on-site neonatal intensive care.
Jiný: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Survival without major neurodevelopmental disability
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mortality
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: At birth
Time from birth to arrival in intensive care and frequency of delay under 60 minutes
At birth
Prognosis
Časové okno: 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
Časové okno: At birth
Frequency of intubations, surfactant administration, and inotropic drugs administration
At birth
Cerebral palsy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Assistance Publique - Hôpitaux de Paris

Vyšetřovatelé

  • Vrchní vyšetřovatel: Peter JONES, MB BChir PhD, SAMU du Val de l'Oise

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. září 2030

Dokončení studie (Odhadovaný)

1. září 2030

Termíny zápisu do studia

První předloženo

14. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

5. května 2026

První zveřejněno (Aktuální)

12. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • APHP251257
  • PREPS-24-0182 (Jiné číslo grantu/financování: French Ministry of Health)
  • 2025-A02162-47 (Jiný identifikátor: ID-RCB)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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