Clinical trial NCT03403894: Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea
Official title: Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Extremely Premature
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child born before 24 weeks of amenorrhea will be study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Existence of cardiac activity
timeFrame: 5 hours
measure: Presence of respiratory movements and/or gasps
timeFrame: 5 hours
measure: Existence of limb movements
timeFrame: 5 hours
measure: Place of care
timeFrame: 5 hours
measure: Identification of the function of the caregiver(s) who performed the care
timeFrame: 5 hours
measure: Conditions of installation of the child (position, skin-to-skin...)
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Céline MARTIN
role: PRINCIPAL_INVESTIGATOR
References: