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

NCT03403894 | Completed

• 1 other identifier: 17-AOI-01
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Extremely Premature

Outcome Measures

Primary Outcomes (6)

• Existence of cardiac activity

  5 hours

• Presence of respiratory movements and/or gasps

  5 hours

• Existence of limb movements

  5 hours

• Place of care

  5 hours

• Identification of the function of the caregiver(s) who performed the care

  5 hours

• Conditions of installation of the child (position, skin-to-skin...)

  5 hours

Interventions

Asking caregivers in their practice BEHAVIORAL

A questionary is given to caregivers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Child born before 24 weeks of amenorrhea will be study.

You may qualify if:

• 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

You may not qualify if:

• \- Child transferred to neonatal intensive care unit.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

Study Officials

• Céline MARTIN

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 19, 2018
• Study Start: November 10, 2018
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)