Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants

NCT07580859 | Not Yet Recruiting

• 3 other identifiers: APHP251257PREPS-24-01822025-A02162-47
• Study Type: observational
• Target: 627
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Prematurity Complications; Neurodevelopment Outcome; Prematurity

Keywords

Prematurity; Outborn; Transport; Mortality; Cohort study; Neurodevelopment

Outcome Measures

Primary Outcomes (1)

• 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.

  at 2 years corrected gestational age

Secondary Outcomes (22)

• Mortality

  From inclusion (birth) up to one year of corrected age

• Severe neurological sequelae

  At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)

• Severe morbidity

  At the end of the initial period of hospitalisation, an average at 4 months after birth (inclusion)

• Hemodynamic, respiratory, and thermal parameters

  At birth

• Time from birth to arrival in intensive care

  At birth

Study Arms (1)

Outborn Infants

Extremely preterm infants born at 23+0-28+6 weeks' gestation in maternity units without on-site neonatal intensive care.

Other: Usual Care

Interventions

Usual Care OTHER

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.

Outborn Infants

Eligibility Criteria

• Age: 0 Days - 28 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

SAMU de Pontoise, Hopital Novo

Pontoise, 95300, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Peter JONES, MB BChir PhD

  SAMU de Paris, Hôpital Necker AP-HP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter JONES, MB BChir PhD

CONTACT

06 12 34 76 82; peter.jones@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)