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Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea

Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03403894
Enrollment
35
Registered
2018-01-19
Start date
2018-11-10
Completion date
2019-09-06
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Extremely Premature

Brief summary

Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most cases, a child born before 24 years of age is stillborn, but in about one in three cases, it shows signs of life such as heartbeat, breathing, gasps or limb movements. With these too small children showing signs of life, three attitudes are possible: doing nothing and waiting for this life to stop by themselves, setting up palliative care to ensure the child's comfort, or administering a medication to shorten his or her life. The attitude to have is not univocal and the feeling of the teams confronted with their management is difficult even if the goal of the caregivers is always to act as best as possible. The main objective of the study is to describe the clinical state of the child and the practices implemented in the birth room at the Nice University Hospital when children showing signs of life before 24 weeks of amenorrhea are born. The secondary objective is to describe caregivers' experiences, their experiences of these situations and attitudes towards children and their parents, and to identify ethical dilemmas in these situations. This study is an observational cohort study including all births of live children before 24 weeks of amenorrhea at Nice University Hospital for 12 months. It consists of two parts: a quantitative study describing the child's condition and caregiving practices, and a qualitative study of caregivers' experiences and the determinants of their attitudes towards the child. The investigator will coordinate the collection of the data necessary to conduct the quantitative study, and then conduct individual semi-directive interviews with each of the caregivers present at the birth of the child. The qualitative study will be based on the analysis of these interviews.

Interventions

BEHAVIORALAsking caregivers in their practice

A questionary is given to caregivers

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Child born before 24 weeks of amenorrhea (term estimated by echographic dating or by the date of the last menstrual period in the absence of ultrasound) * Inscription in the birth register (so from 15 weeks of amenorrhea) * Non-opposition of the parents

Exclusion criteria

\- Child transferred to neonatal intensive care unit.

Design outcomes

Primary

MeasureTime frame
Existence of cardiac activity5 hours
Presence of respiratory movements and/or gasps5 hours
Existence of limb movements5 hours
Place of care5 hours
Identification of the function of the caregiver(s) who performed the care5 hours
Conditions of installation of the child (position, skin-to-skin...)5 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026