MedTrace Logo

Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants

NCT07580859 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 627

Last updated 2026-05-28

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Peter JONES, MB BChir PhD · SAMU du Val de l'Oise

Eligibility

Min Age
0 Days
Max Age
28 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2030-09-30
Completion
2030-09-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07580859 on ClinicalTrials.gov