OutBorn: Study of the Short-term Mortality and Morbidity of Newborns Born at a Gestational Age <32 Weeks of Amenorrhea

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05150301

Collaborator

(none)

134

Enrollment

Location

11.9

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An "outborn" birth is a premature birth that occurs in an unsuitable level center at the end of the child (unlike "inborn" births).

This study aims to describe the morbidity and mortality of very premature newborns (gestational age less than 32 weeks of amenorrhea) born outside a maternity hospital of appropriate level between January 1, 2016 and December 31, 2020, and assessment of the preventable or non-preventable nature of these so-called "outborn" births.

The aim of this research is to write down the short-term mortality and morbidity of newborns born at a gestational age <32 weeks of amenorrhea outside a level III maternity hospital in Alsace between January 1, 2016 and December 31, 2020.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth

Study Design

Study Type:

Observational

Anticipated Enrollment :

134 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Study of the Short-term Mortality and Morbidity of Newborns Born at a Gestational Age <32 Weeks of Amenorrhea Outside a Level III Maternity Hospital in Alsace

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Outcome Measures

Primary Outcome Measures

Study of the short-term mortality and morbidity of newborns born at a gestational age <32 weeks of amenorrhea [Files analysed retrospectively from January 01, 2016 to December 31, 2010 will be examined]]

Eligibility Criteria

Criteria

Ages Eligible for Study:

32 Weeks and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Newborn under 32 weeks of amenorrhea at the time of birth, born in Alsace in one of the level I, IIa, or IIb maternity hospitals, between January 1, 2016 and December 31, 2020