Preterm Infants Born to Homeless Mothers.

Prematurity; Extreme Clinical Trial

— PREMA-NEUF  

Official title:

Observation of the Fate and Quality of Medical Follow-up of Children Born Preterm to Homeless Mothers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684419
• Other study ID #: CHRD0522
• Status: Completed
• Start date: July 29, 2022
• Est. completion date: August 12, 2023

Study information

• Verified date: January 2024
• Source: Hôpital NOVO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Premature Birth
• Prematurity; Extreme

Intervention

Other:
• Fate and quality of medical follow-up of children born very premature (=33SA) to homeless mothers
Evaluation of the fate and quality of medical follow-up of children born very premature (=33SA) to homeless mothers.

Locations

Country	Name	City	State
France	Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome

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