Prematurity at the Limit of Viability

NCT06391476 | Completed

• 1 other identifier: CRC_GHN_2024_001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Very Preterm Maturity of Infant

Keywords

Prematurity; Morbi-mortality; Neurosensory development

Outcome Measures

Primary Outcomes (1)

• Mortality

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

  up to 24 months corrected age

Study Arms (1)

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

Interventions

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.

Extremely preterm infants, born between 22 and 25 weeks gestational age

Eligibility Criteria

• Age: 22 Weeks - 25 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Croix Rousse

Lyon, Rhone, 69004, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Gestational Age

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fetal Development; Embryonic and Fetal Development; Morphogenesis; Growth and Development; Physiological Phenomena; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 30, 2024
• Study Start: January 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

FR (1)