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Completed

NCT Number: NCT06391476

Prematurity 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.

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Key information

Age range

22 week–25 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Croix Rousse

Lyon, Rhone, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study of the evolution of a cohort of children born between 22 and 25 weeks gestational age

Other
  • 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.

Primary outcomes

  1. Mortality

    Time frame: up to 24 months corrected age

    Proportion of deaths in a cohort of infants born between 22 - 25 weeks gestational age

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PRELIVIA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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