Preterm Infants Born to Homeless Mothers.
PREMA-NEUF
Observation of the Fate and Quality of Medical Follow-up of Children Born Preterm to Homeless Mothers.
1 other identifier
observational
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2022
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
December 16, 2022
CompletedFirst Posted
Study publicly available on registry
January 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2023
CompletedSeptember 19, 2024
January 1, 2024
6 months
December 16, 2022
September 3, 2024
Conditions
Keywords
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
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
- Hôpital NOVOlead
Study Sites (1)
Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos
Pontoise, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Suzanne BORRHOMEE
Hôpital NOVO
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