NCT05684419

Brief Summary

In recent years, the number of homeless patients who are accommodated by the SAMU social has increased. These patients are in a situation of financial, but also often social and psychological precariousness. The literature already shows us that precariousness and homelessness are a risk factor for prematurity, but also for the patients themselves, a risk of more frequent recourse to emergency services and of late consultation for advanced pathologies. The objective of this study is to evaluate the fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2023

Completed
Last Updated

September 19, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

December 16, 2022

Last Update Submit

September 3, 2024

Conditions

Keywords

PrematureHomelessExtreme prematurity

Outcome Measures

Primary Outcomes (1)

  • Assessment of the rate of infants born to homeless mothers at or below 33 SA and lost to follow-up for extreme prematurity

    Measurement of the number of children lost to follow-up at 12 months who missed their last follow-up appointment(s) organized in the context of prematurity, with no reason given or new schedule planned

    At 12 month

Secondary Outcomes (7)

  • Assessment of the compliance of homeless mothers with medical prescriptions and the respect of the instructions given for the course of care (treatments, physiotherapy, appointment scheduling, etc.)

    At 12 month

  • Assessment of vaccination rates in infants born at or below 33 days' gestation to homeless mothers

    At 12 month

  • Assessment of the organized follow-up in the city of infants born at a term less than or equal to 33 days of age, of homeless mothers (between the PMI and the attending physicians)

    At 6 month

  • Assessment of the rate of re-hospitalization and consultation in the emergency room of the René Dubos Hospital for infants born at a term less than or equal to 33 days of age, of homeless mothers

    At 12 month

  • Assessment of breastfeeding duration at 6 months in infants born at or below 33 days' gestation to homeless mothers

    At 6 month

  • +2 more secondary outcomes

Interventions

Evaluation of the fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers.

Eligibility Criteria

AgeUp to 33 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All infants born at or below 33SA: * Born between January 2019 and December 2021 * At the René Dubos Hospital in Pontoise * Whose mother did not have a fixed address at the time of discharge.

You may qualify if:

  • All infants born at or below 33SA:
  • Born between January 2019 and December 2021
  • At the René Dubos Hospital in Pontoise
  • Whose mother did not have a fixed address at the time of discharge.
  • NB: Mothers who do not read French well will have the study explained to them by the doctor who follows their child during a consultation, or by telephone.

You may not qualify if:

  • \- Opposition of the mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos

Pontoise, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Dr Suzanne BORRHOMEE

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 16, 2022

First Posted

January 13, 2023

Study Start

July 29, 2022

Primary Completion

January 17, 2023

Study Completion

August 12, 2023

Last Updated

September 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations