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

Premature Birth Clinical Trial

— OutBorn  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150301
• Other study ID #: 8425
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: November 2021
• Source: University Hospital, Strasbourg, France
• Contact: Benoit ESCANDE, MD
• Phone: 33 3 88 12 77 93
• Email: benoit.escande[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: October 30, 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks and older

Eligibility

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

Exclusion criteria:

• Fetal death in utero

Related Conditions & MeSH terms

• Amenorrhea
• Premature Birth

Locations

Country	Name	City	State
France	Service de Réanimation Néonatale - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]