Preterm Infants Born to Homeless Mothers.

Completed

• Conditions: Prematurity; Extreme

• Registration Number: NCT05684419
• Lead Sponsor: Hôpital NOVO

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.

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 Timeline

• Study Start: 2022-07-29
• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-13
• Primary Completion: 2023-01-17
• Study Completion: 2023-08-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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
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
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

Trial Locations

Locations (1)

Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos; 🇫🇷 Pontoise, France