Prematurity at the Limit of Viability (PRELIVIA)

Morbi-mortality and Development at 2 Years in Infants Born at the Limit of Viability

Advancements in perinatal care have significantly improved the survival of extremely premature infants, establishing a viability threshold below 25 weeks' gestational age (GA). However, management at the limit of viability poses ethical and decision-making problems for health-care professionals. They grapple with the delicate balance between potential survival and long-term disabilities.

These decisions, as well as the information given to families, are based on knowledge of the prognosis as assessed by national and international epidemiological studies. Healthcare professionals rely on population-based estimations but face discrepancies in predicting outcomes because there are significant variation depending on perinatal center and country where infants are hospitalized. In the large French epidemiological study, 9,6% of livebirths included were born at 22-25 wks and only 38% survived.

In the neonatology department of the croix rousse, these infants have been actively cared for for many years, which has allowed the development of specific skills that are essential for the proper management of these very high-risk patients. Furthermore, EPIPAGE 2 included data from centers where perinatal management was probably not very active at these extreme ages. It results in worse neonatal outcomes as evaluated at the national level than outcomes data evaluated at the neonatal intensive care unit of Croix-Rousse hospital. Using data from EPIPAGE 2 study for clinical decision could lead to avoid active care at the for some infants at the limit of viability It is needed to obtain complete evaluation of neonatal outcomes of infants hospitalized at the Croix-Rousse hospital, so that clinicians may rely on actualized data related to the practices in their perinatal center. It is also needed to compare outcomes with data from large national and international cohorts, to identify and quantify differences. Data about later neurodevelopment outcomes, at 2 years, are also needed as it can taken in consideration in decision-making process.

Study Overview

• Status: Completed
• Conditions: Very Preterm Maturity of Infant
• Intervention / Treatment: Other: Study of the evolution of a cohort of children born between 22 and 25 weeks gestational age

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Rhone
    • Lyon, Rhone, France, 69004
      • Hôpital Croix Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Extremely premature newborn (between 22 and 25 weeks gestational age) treated at the Croix-Rousse hospital

Description

Inclusion Criteria:

• Infants born between 22 and 25 weeks gestational age
• Infants hospitalized at the tertiary care neonatal unit of Croix-Rousse hospital
• Infants born between January 2010 and December 2019

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Extremely preterm infants, born between 22 and 25 weeks gestational age; Infant born between 22 and 25 weeks gestational age and hospitalized at the Croix-Rousse Hospital	Other: Study of the evolution of a cohort of children born between 22 and 25 weeks gestational age; Study of mortality in a cohort of children born between 22 and 25 weeks gestational age; Study of neonatal morbidity; Description of postnatal growth; Description of nutrition and breastfeeding at discharge; Study of the neurological, respiratory and growth outcome at 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Proportion of deaths in a cohort of infants born between 22 - 25 weeks gestational age	up to 24 months corrected age

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Prematurity; Morbi-mortality; Neurosensory development
• Other Study ID Numbers: CRC_GHN_2024_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No