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

NCT06078618 | Completed

• 1 other identifier: DESPLANCHES APJ 2021
• Study Type: observational
• Target: 240,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Between 32 and 36 Weeks of Amenorrhoea

Outcome Measures

Primary Outcomes (2)

• Mortality rate

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

  up to 28 days after birth

• Neonatal morbidity rate

  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.

  up to 28 days after birth

Study Arms (1)

cohort

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

Eligibility Criteria

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

Study Population

Retrospective cohort based on an extraction from the National Health Data System (SNDS) and including all pregnant women giving birth between 32 and 36 completed weeks of amenorrhoea, between 1st January 2015 and 31st December 2020 in France and their newborn babies (live or stillborn).

You may qualify if:

• 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.

You may not qualify if:

• Births in very small maternity units
• Births in hospitals without an obstetrics unit
• Births outside hospitals.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Study Design

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

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 12, 2023
• Study Start: January 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

FR (1)