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PREM3236: Place of Birth and Neonatal Health in Cases of Premature Birth Between 32 and 36 Weeks of Amenorrhoea

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT06078618
Collaborator
(none)
240,000
Enrollment
1
Location
14.9
Actual Duration (Months)
16090.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental sequelae compared with full-term newborns.

In the case of preterm birth, optimal antenatal, birth and postnatal management is necessary to prevent neonatal complications and mitigate longer-term consequences. However, we lack knowledge about the management of this at-risk population and the factors influencing their health.

This knowledge is needed in the current context of unfavourable trends in neonatal health. Over the last ten years, neonatal and infant mortality has stagnated in France, with France falling behind other European countries. According to the latest European report, France ranks 22nd out of 33 countries. The causes of this stagnation are not well known, but many hypotheses have been put forward, including sub-optimal organisation of care.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    240000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Place of Birth and Neonatal Health in Cases of Preterm Birth Between 32 and 36 Weeks of Amenorrhoea: a National Population-based Study
    Actual Study Start Date :
    Jan 1, 2022
    Actual Primary Completion Date :
    Mar 31, 2023
    Actual Study Completion Date :
    Mar 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    cohort

    Mothers and their newborn babies (live or stillborn) who were delivered between 32 and 36 weeks' gestation

    Outcome Measures

    Primary Outcome Measures

    1. Mortality rate [up to 28 days after birth]

      Mortality (stillbirths, neonatal mortality before 28 days, hospital mortality)

    2. Neonatal morbidity rate [up to 28 days after birth]

      Neonatal morbidity. Composite indicator of neonatal morbidity defined by 18 ICD 10 and/or CCAM diagnostic codes and including the following sub-categories: respiratory, infectious, neurological, metabolic pathologies and obstetric trauma.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Days and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All mothers and their newborn babies (live or stillborn) who had a delivery stay between 32 and 36 days of age recorded in the PMSI between 01/01/2015 and 31/12/2020.
    Exclusion Criteria:

    • Births in very small maternity units

    • Births in hospitals without an obstetrics unit

    • Births outside hospitals.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Dijon Bourgogne Dijon France 21000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Dijon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire Dijon
    ClinicalTrials.gov Identifier:
    NCT06078618
    Other Study ID Numbers:
    • DESPLANCHES APJ 2021
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Premature Birth
    Amenorrhea

    Study Results

    No Results Posted as of Oct 12, 2023