Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-28
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Usual Care

Treatment groups

627 Participants
are divided into 1 treatment group