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

NCT05150301 | Unknown

• 1 other identifier: 8425
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Premature Birth; Outborn; Newborns; Gestational age

Outcome Measures

Primary Outcomes (1)

• 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

• Age: 32 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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

You may not qualify if:

• \- Fetal death in utero

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Réanimation Néonatale - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Benoit ESCANDE, MD

  Service de Réanimation Néonatale - Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoit ESCANDE, MD

CONTACT

33 3 88 12 77 93; benoit.escande@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

said.chayer@chru-strasbourg.fr

Study Design

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

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 9, 2021
• Study Start: November 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 30, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

FR (1)