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

26 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

627

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Peter JONES, MB BChir PhD
  • Numero di telefono: +33 06 12 34 76 82
  • Email: peter.jones@aphp.fr

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Outborn Infants
Extremely preterm infants born at 23+0-28+6 weeks' gestation in maternity units without on-site neonatal intensive care.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Survival without major neurodevelopmental disability
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mortality
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At birth
Time from birth to arrival in intensive care and frequency of delay under 60 minutes
At birth
Prognosis
Lasso di tempo: 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
Lasso di tempo: At birth
Frequency of intubations, surfactant administration, and inotropic drugs administration
At birth
Cerebral palsy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigatori

  • Investigatore principale: Peter JONES, MB BChir PhD, SAMU du Val de l'Oise

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 settembre 2030

Completamento dello studio (Stimato)

1 settembre 2030

Date di iscrizione allo studio

Primo inviato

14 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • APHP251257
  • PREPS-24-0182 (Altro numero di sovvenzione/finanziamento: French Ministry of Health)
  • 2025-A02162-47 (Altro identificatore: ID-RCB)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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