Prematurity at the Limit of Viability

NCT ID: NCT06391476

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 22 Weeks
• Maximum Eligible Age: 25 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Croix Rousse

Lyon, Rhone, France

Countries

France

Other Identifiers

CRC_GHN_2024_001

Identifier Type: -

Identifier Source: org_study_id