Prematurity; Extreme Clinical Trial
— PREMA-NEUFOfficial title:
Observation of the Fate and Quality of Medical Follow-up of Children Born Preterm to Homeless Mothers.
NCT number | NCT05684419 |
Other study ID # | CHRD0522 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 29, 2022 |
Est. completion date | August 12, 2023 |
Verified date | January 2024 |
Source | Hôpital NOVO |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 12, 2023 |
Est. primary completion date | January 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 33 Weeks |
Eligibility | Inclusion 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. 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. Exclusion Criteria : - Opposition of the mothers |
Country | Name | City | State |
---|---|---|---|
France | Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos | Pontoise |
Lead Sponsor | Collaborator |
---|---|
Hôpital NOVO |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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.) | Measurement of the compliance rate of homeless mothers with medical prescriptions (treatments, physical therapy, appointment scheduling, etc.) at 12 months | At 12 month | |
Secondary | Assessment of vaccination rates in infants born at or below 33 days' gestation to homeless mothers | Measure of the number of children with full immunization among children born at 33 SA or less to homeless mothers at 12 months | At 12 month | |
Secondary | 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) | Description of the type of organized follow-up in town 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, spacing of appointments), evaluated at 6 months | At 6 month | |
Secondary | 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 | Measurement of the number of re-hospitalizations and emergency room visits at the René-Dubos Hospital for infants born at a term of less than or equal to 33 weeks of age, to homeless mothers, evaluated at 12 months | At 12 month | |
Secondary | Assessment of breastfeeding duration at 6 months in infants born at or below 33 days' gestation to homeless mothers | Measurement of breastfeeding duration in weeks, assessed at 6 months, in infants born at or below 33 SA to homeless mothers | At 6 month | |
Secondary | Assessment of the type of feeding on the duration of follow-up in infants born at a term less than or equal to 33 SA, of homeless mothers | Description of the type of feeding (breastfeeding, industrial milk, diversification) in infants born at a term less than or equal to 33 SA, of homeless mothers | At 12 month | |
Secondary | Assessment of staturo-weight growth during follow-up in infants born at or below 33 SA born to homeless mothers | Analysis of the staturo-weight growth curve (weight and Z score) in infants born at a term of less than or equal to 33 SA, to homeless mothers | At 12 month |
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