Prematurity; ExtremePREMA-NEUFNCT05684419
Preterm Infants Born to Homeless Mothers.
An observational study of Prematurity; Extreme, run by Hôpital NOVO at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 33 weeks
- Conditions the study is for
- Prematurity; Extreme
- What is being tested?
- Fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2022to 12 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 33 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Opposition of the mothers
Trial locations and contacts
1 site in 1 country.
France1 site
Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos
Pontoise
About this study
Official title: Observation of the Fate and Quality of Medical Follow-up of Children Born Preterm 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.
Read the 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?
- Conditions
- Prematurity; Extreme
- Being tested
- Fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers
- Keywords
- Premature, Homeless, Extreme prematurity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothersOther
Evaluation of the fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 12 month
Secondary outcomes (7)
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
Measured: At 12 month
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
Measured: At 12 month
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
Measured: At 6 month
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
Measured: At 12 month
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
Measured: At 6 month
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
Measured: At 12 month
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
Measured: At 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start29 Jul 2022
- Primary completion17 Jan 2023
- Study completion12 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity; ExtremeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Suzanne BORRHOMEE, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684419
- Sponsor's protocol ID
- CHRD0522
- Acronym
- PREMA-NEUF
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Fate and Quality of Medical Follow-up of Children Born Preterm to Homeless Mothers.
- ClinicalTrials.gov ID
- NCT05684419
- Acronym / sponsor ID
- PREMA-NEUF / CHRD0522
- Conditions
- Prematurity; Extreme
- Keywords
- Premature, Homeless, Extreme prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 12 Aug 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Opposition of the mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothersEvaluation of the fate and quality of medical follow-up of children born very premature (≤33SA) to homeless mothers. | Other | – |
Primary outcome
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
7 secondary outcomes
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
Assessment of vaccination rates in infants born at or below 33 days' gestation to homeless mothers
Time frame: At 12 month
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
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
Assessment of breastfeeding duration at 6 months in infants born at or below 33 days' gestation to homeless mothers
Time frame: At 6 month
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Suzanne BORRHOMEE principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity; Extreme, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.