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Completed

NCT Number: NCT06078618

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

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.

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Key information

Conditions

Premature Between 32 and 36 Weeks of Amenorrhoea

Age range

0 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality rate

    Time frame: up to 28 days after birth

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

  2. Neonatal morbidity rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Place of Birth and Neonatal Health in Cases of Preterm Birth Between 32 and 36 Weeks of Amenorrhoea: a National Population-based Study

Acronym: PREM3236

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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