Skip to main content
OpenTrials
Completed

NCT Number: NCT05684419

Preterm Infants Born to Homeless Mothers.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prematurity; Extreme Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 33 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos

Pontoise, France

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers

Other

Evaluation of the fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers.

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

    Time frame: 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 outcomes

  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.)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: PREMA-NEUF

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.