Impact of an intervention standardizing the perinatal management of extremely preterm infants on the child's survival without severe morbidity: a stepped-wedge cluster-randomized trial (PREMEX study).

BACKGROUND AND

objectiveExtremely preterm infants are at very high risk of neonatal death and disabilities. Their survival rate is much variable in developed countries and in France is much lower than other countries. Our objective is to evaluate the impact of an intervention to standardize the perinatal management of extremely preterm infants. POPULATION: Women hospitalized between 22 and 26 weeks for risk of preterm delivery with a alive fetus or a stillbirth at admission and with a delivery between 22 and 26 completed weeks.

interventionOur complex intervention aimed at standardizing the organization of care based on the following principles: A collective obstetric-pediatric prognostic assessment, in a non-emergency setting, with a consensus decision about the obstetric and neonatal management proposed-either active or palliative care; An interview with the parents to inform them, answer their questions, propose either active or palliative care and then ask their opinion.

methodsA Stepped-wedge cluster-randomized trial. Perinatal networks will be randomly allocated to the intervention in 5 waves every 3 months, with a total recruitment period of 21 months (including 3-month transition periods). All perinatal networks will have a period with and without the intervention. After the allocation of clusters to the intervention period, the teams will be trained in the intervention protocol and then will undergo a 3-month transition period to learn the protocol thoroughly. SAMPLE SIZE: We hypothesis hypothesized is that survival without severe morbidity will could rise from 20 to 35% after the intervention, but envisaged different scenarios with varying survival without severe morbidity in the control and intervention periods. The intraclass correlation coefficients was set to 0.07. With an average number of 60 to 70 extremely preterm infants recruited per year, a number of 20 clusters (perinatal networks) were was sufficient to provide at least 80% power in most scenarios, and 25 clusters would provide at least 80% power in all scenarios envisaged.

settingTwenty-five perinatal networks including 34 neonatal level-3 hospital, and 285 maternity units overall. OUTCOME: Child's survival without severe morbidity at hospital discharge. EXPECTED

resultsImprovement of the health of extremely preterm infants and, if the intervention shows that it is effective, equitable access to care according to place of birth in France. ETHICS: The protocol was approved by the Committee for Protection of Persons Involved in Biomedical Research (CPP Ile de France V PARIS), and the French Data Protection Authority (30/12/2021, N°21.03700000050-MS02).

trial registrationThe trial was registered before the beginning of the study at ClinicalTrials.gov (December 20, 2021-NCT05248477).