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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Unknown status
CT.gov ID
NCT03403894
Collaborator
(none)
20
1
30
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Asking caregivers in their practice

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea
Anticipated Study Start Date :
Feb 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Aug 1, 2020

Outcome Measures

Primary Outcome Measures

  1. Existence of cardiac activity [5 hours]

  2. Presence of respiratory movements and/or gasps [5 hours]

  3. Existence of limb movements [5 hours]

  4. Place of care [5 hours]

  5. Identification of the function of the caregiver(s) who performed the care [5 hours]

  6. Conditions of installation of the child (position, skin-to-skin...) [5 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nice Nice France 06003

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: CĂ©line MARTIN, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT03403894
Other Study ID Numbers:
  • 17-AOI-01
First Posted:
Jan 19, 2018
Last Update Posted:
Jan 19, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2018