PREMA-NEUF: Preterm Infants Born to Homeless Mothers.

Sponsor
Centre Hospitalier René Dubos (Other)
Overall Status
Recruiting
CT.gov ID
NCT05684419
Collaborator
(none)
36
1
7.1
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers

Detailed Description

The hospital of Pontoise is the largest maternity hospital in the department (Val d'Oise, 95) with 4449 births in 2021. It has a type 3 neonatal intensive care unit where approximately 150 premature babies under 32 weeks of age are hospitalized each year, including 80 premature babies under 28 weeks of age. These children require a specific and prolonged follow-up after hospitalization, including medical consultations to evaluate their neurodevelopmental development, but also the prevention of RSV infection (Respiratory Syncitial Virus).

In recent years, the number of homeless patients who are accomodated by the SAMU social has increased. These patients are in a precarious financial, but also often social and psychological situation. 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 late consultation with advanced pathologies.

The aim of this study is to evaluate the fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers, by answering the following questions:

  • What about the follow-up of their very premature child?

  • How does the department organize itself to ensure optimal follow-up for these patients?

Study Design

Study Type:
Observational
Anticipated Enrollment :
36 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Observation of the Fate and Quality of Medical Follow-up of Children Born Preterm to Homeless Mothers.
Actual Study Start Date :
Jul 29, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Assessment of the rate of infants born to homeless mothers at or below 33 SA and lost to follow-up for extreme prematurity [At 12 month]

    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

Secondary Outcome Measures

  1. 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]

    Measurement of the compliance rate of homeless mothers with medical prescriptions (treatments, physical therapy, appointment scheduling, etc.) at 12 months

  2. Assessment of vaccination rates in infants born at or below 33 days' gestation to homeless mothers [At 12 month]

    Measure of the number of children with full immunization among children born at 33 SA or less to homeless mothers at 12 months

  3. 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]

    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

  4. 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]

    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

  5. Assessment of breastfeeding duration at 6 months in infants born at or below 33 days' gestation to homeless mothers [At 6 month]

    Measurement of breastfeeding duration in weeks, assessed at 6 months, in infants born at or below 33 SA to homeless mothers

  6. 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 [At 12 month]

    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

  7. Assessment of staturo-weight growth during follow-up in infants born at or below 33 SA born to homeless mothers [At 12 month]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 33 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos Pontoise France

Sponsors and Collaborators

  • Centre Hospitalier René Dubos

Investigators

  • Principal Investigator: Dr Suzanne BORRHOMEE, Centre Hospitalier René Dubos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier René Dubos
ClinicalTrials.gov Identifier:
NCT05684419
Other Study ID Numbers:
  • CHRD0522
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier René Dubos
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2023