Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Survival without major neurodevelopmental disability — 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.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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