Skip to main content
OpenTrials
Completed

NCT Number: NCT03403894

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infant, Extremely Premature

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, 06003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Asking caregivers in their practice

Behavioral

A questionary is given to caregivers

Primary outcomes

  1. Existence of cardiac activity

    Time frame: 5 hours

  2. Presence of respiratory movements and/or gasps

    Time frame: 5 hours

  3. Existence of limb movements

    Time frame: 5 hours

  4. Place of care

    Time frame: 5 hours

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

    Time frame: 5 hours

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

    Time frame: 5 hours

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2018
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.