Not Yet RecruitingNot Applicable

Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants

France627 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range

0 Days – 28 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival without major neurodevelopmental disability

Timeframe: at 2 years corrected gestational age

Trial details

NCT IDNCT07580859

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-09

Contact for this trial

Peter JONES, MB BChir PhD

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

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