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

NCT ID: NCT05150301

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Birth

Keywords

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Premature Birth Outborn Newborns Gestational age

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benoit ESCANDE, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Réanimation Néonatale - Hôpitaux Universitaires de Strasbourg

Locations

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Service de Réanimation Néonatale - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Benoit ESCANDE, MD

Role: CONTACT

Phone: 33 3 88 12 77 93

Email: [email protected]

Saïd CHAYER, PhD, HDR

Role: CONTACT

Email: [email protected]

Facility Contacts

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Benoit ESCANDE, MD

Role: primary

Saïd CHAYER, PhD, HDR

Role: backup

Other Identifiers

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8425

Identifier Type: -

Identifier Source: org_study_id