Food InsecurityANJE NutriNCT06528275
Infant Feeding in French Guiana
An observational study of Food Insecurity and Pregnancy Related, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial summary
This is a comparative, observal study among the population of pregant women who participated to the study "Nutri Pou Ti Moun" on food insecurity during pregnancy in French Guiana Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Pregnancy Related
- What is being tested?
- Health promotion intervention
- How many people
- 380 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 14 Mar 2024to Aug 2026
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women living in French Guiana who participated to the Nutri Pou Ti Moun project and who benefited or not from a health promotion intervention on nutrition
Who may be able to join
- Intervention group : women included in Nutri Pou Ti Moun project and who benefited from health promotion intervention
- Control group : women included in Nutri Pou Ti Moun project and who did not benefit from health promotion intervention
Who cannot join
- Women refusing to participate to the study
- Women who moved out of French Guiana
- Women lost for follow up or who could not be contacted for the participation to the study
- Minor women who could not obtain authorisation from legal representatives
Trial locations and contacts
1 site in 1 country.
French Guiana1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Cayenne
Cayenne, 97300
Celia BASURKO, MD, +594 5 94 39 57 66, celia.basurko@ch-cayenne.fr
Mathieu NACHER, PhD, +594 5 94 39 53 85, mathieu.nacher@ch-cayenne.fr
About this study
Official title: Food Insecurity During Pregnancy in French Guiana - Focus on Infant Feeding
This is a comparative, observal study among the population of pregant women who participated to the study "Nutri Pou Ti Moun" on food insecurity during pregnancy in French Guiana
Read the detailed description
The international literature has already demonstrated the benefits of breastfeeding (BF) in the short, medium and long term for the health of children and mothers alike. For children, breastfeeding helps to reduce mortality from infections, prevents hospitalisations, particularly for gastroenteritis and respiratory illnesses, and prevents diabetes and childhood obesity. Breastfeeding also plays an important role in children's cognitive development, with an impact on IQ and academic success. For mothers, not breastfeeding is associated with an increased risk of breast and ovarian cancer, type II diabetes, obesity and cardiovascular disorders. Similarly, the WHO recommends optimal feeding practices for infants up to 2 years of age, i.e. early initiation of breastfeeding to allow the child to receive colostrum, exclusive BF for 4 to 6 months, and the timely introduction of liquid, semi-solid or solid foods, the continuation of BF for up to 2 years and beyond, the consumption of age-appropriate infant formula (IF) as an alternative to breastfeeding, and a minimum acceptable intake of complementary food to breast or infant milk.
On a national scale, the 'first 1000 days' initiative (from the 4th month of pregnancy to the child's 2nd birthday) that emerged at the symposium on 23 September 2021 organised by Santé Publique France and the French Ministry of Solidarity and Health includes the objective of promoting good BF practices. Similarly, the 2019-2023 national nutrition and health plan (PNNS4) aims to increase the percentage of children breastfed at birth by at least 15% and to extend the median duration of total breastfeeding by 2 weeks. In French Guyana, the 2023-2028 regional health plan points out that perinatal indicators in the French overseas territories are worse than in mainland France, and that improving mother and child health must involve improving the environment in which children live during their first 1,000 days.
In 2005, an initial retrospective study of breastfeeding practices was carried out in western part of French Guiana and showed a rate of exclusive breastfeeding at 4 months of age of 3% and a rate of continued breastfeeding of 16.7% up to 1 year and 6.5% up to 2 years. Between 2010 and 2012, a prospective survey of the whole of French Guiana found an exclusive BF rate of 27% at 1 month, 9% at 3 months and 5% at 6 months. In the Epifane survey conducted in France between 2010 and 2012, the rate of exclusive breastfeeding at 1 month and 3 months was close to that in French Guiana (28% and 10% respectively), with an average duration of exclusive or predominant breastfeeding of 3 weeks.
The rate of continued breastfeeding for up to 1 year was estimated at 16% in the Guiana study, compared with 9% in France. The rate of mixed breastfeeding concerned 30% of women breastfeeding from the maternity hospital in French Guiana, compared with 20% in France. The main reasons for introducing bottles of infant formula (IF) in both French Guiana and France were the impression of a lack of milk (the child's feeling of dissatisfaction) and the return to work. On the other hand, almost 1 in 2 women in French Guiana stated that no healthcare professional had shown any interest in their breastfeeding at 1 month post-partum.
Since January 2023, the Nutri Pou Ti'moun study ('Nutri 1 project' ID-RCB 2022-A01772-41), carried out in 3 maternity units in French Guiana and involving 800 women who have given birth - the 'Nutri 1 women's group' - aims to take stock of women's food insecurity during pregnancy and to describe the medical consequences observed on the course and outcome of pregnancy and on infant health in the immediate post-partum period. In the course of this project, the links between vitamin and mineral deficiencies, heavy metal impregnation and maternal dietary diversification are being studied. In the Guianese context of multidimensional precariousness, the Guianese perinat network, in partnership with local and institutional players, aimed to set up a health and nutrition pathway from the 4th month of pregnancy in October 2023, comprising weekly workshops co-hosted by a health mediator (on diet, well-being, adapted physical activities and the promotion of breastfeeding) and the distribution of baskets of fresh, local fruit and vegetables.
This health promotion intervention is offered to pregnant women attending the maternal and child health protection centre (PMI) in the Communauté d'agglomération du centre littoral (CACL) - the 'Nutri 2 women's group'. This intervention gave rise to an ancillary research project to the Nutri Pou Ti'moun research project, the Nutri pou ti'moun 2 project (Nutri 2 project; ID-RCB 2023-A00167-38) aimed at assessing the impact of this action on women's diet (diversity and food insecurity) by comparing the data from the Nutri 1 women's group with that from the Nutri 2 women's group. These projects only cover the period from pregnancy to the immediate post-partum period. By 31 December 2023, 786 women had been included in the Nutri 1 project and 57 women in the ancillary Nutri 2 project.
The relevance and interest of conducting research in French Guiana on breastfeeding practices and, more broadly, on infant feeding are justified:
- On the one hand, by the absence of recent published data on infant feeding practices in French Guiana. The second national Epifane survey, to be carried out in 2021 and focusing on infant nutrition during the first year of life, is a study being conducted in parallel with the national perinatal survey in France. An extension of this survey was carried out in the French overseas departments and territories, but French Guiana was not included.
- On the other hand, the Nutri Pou Ti Moun project represents an opportunity to collect data on infant feeding from a representative sample of women giving birth in French Guiana, in the three public maternity hospitals (Nutri 1 group of women). Medical, biomedical and socio-demographic data, as well as data relating to food safety and nutrition during pregnancy already collected during the Nutri Pou Ti moun project, will be analysed with regard to infant feeding practices and child development data (staturo-weight, cranial perimeter, psychomotor development). The impact of a prenatal intervention on nutrition could also be assessed by comparing infant feeding data for children in the Nutri 1 group and those in the Nutri 2 group.
In a socio-economic and health context that is different from that in mainland France, food insecurity in French Guiana during pregnancy, as assessed in the Nutri Pou Ti moun project, is likely to have consequences for young children that it would be relevant to measure and compare with national and international data. In the short term, the impact of this food insecurity would influence the use and duration of breastfeeding, the occurrence of anaemia in young children and dietary practices; and in the medium term, the child's staturo-weight development and cognitive development.
- Conditions
- Food Insecurity, Pregnancy Related
- Being tested
- Health promotion intervention
- Keywords
- Infant feeding, Breastfeeding, Food insecurity, Pregnancy, French Guiana
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion interventionOther
Health promotion intervention with activites linked to nutrition, and distribution of baskets of fresh fruits and vegetables
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - control | Pregant women included in Nutri Pou Ti Moun 1 project who did not benefit from the health promotion intervention | |
| Group 2 - intervention | Pregant women included in Nutri Pou Ti Moun 1 project who benefited from the health promotion intervention Receives: Other: Health promotion intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of exclusive breastfeeding at 3 months of age in French Guiana
To estimate the prevalence of exlusive breastfeeding at 3 months of age in French Guiana in the group control and the group intervention
Measured: At inclusion
Secondary outcomes (9)
Description of exclusive breastfeeding practices
To describe exclusive breasfeeding practices by questionnaire
Measured: At inclusion
Description of artificial breastfeeding practices
To describe artificial breastfeeding practices by questionnaire
Measured: At inclusion
Description of dietary diversity in infants
To describe dietary diversity in infants by questionnaire
Measured: At inclusion
Description of the minimal dietary diversity
To describe the minimal dietary diversity for children 6-23 months (MDD-IYCF) at 12 months of age by questionnaire
Measured: 12 months
Description of the minimal dietary diversity of mothers
To describe the minimal dietary diversity of mothers (MDD-W) at 12 months of age of the baby by questionnaire
Measured: 12 months
Description of staturo-ponderal and psychomotor development indicators
Prevalence of staturo-ponderal and psychomotor development indicators among infants during their 1st year of age
Measured: 12 months
Breastfeeding rate, exclusive and artificial breastfeeding duration, dietary diversity between groups
Comparison of breastfeeding rate, exclusive and artificial breastfeeding duration, dietary diversity and age at diversity between the 2 groups
Measured: 12 months
Description of breastfeeding practices from mothers point of view
To describe views on breastfeeding practices in intervention group by semi-structured interview
Measured: At inclusion
Description of breastfeeding practices from professionals point of view
To describe views on breastfeeding practices in professionals by semi-structured interview
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start14 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celia BASURKO, MD, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528275
- Sponsor's protocol ID
- ANJE Nutri
- Acronym
- ANJE Nutri
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
PubMed 26869575Sankar MJ, Sinha B, Chowdhury R, Bhandari N, Taneja S, Martines J, Bahl R. Optimal breastfeeding practices and infant and child mortality: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):3-13. doi: 10.1111/apa.13147.
PubMed 26249674Horta BL, Loret de Mola C, Victora CG. Long-term consequences of breastfeeding on cholesterol, obesity, systolic blood pressure and type 2 diabetes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):30-7. doi: 10.1111/apa.13133.
PubMed 26192560Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
PubMed 26792873Chowdhury R, Sinha B, Sankar MJ, Taneja S, Bhandari N, Rollins N, Bahl R, Martines J. Breastfeeding and maternal health outcomes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):96-113. doi: 10.1111/apa.13102.
PubMed 26172878Basurko C, Dupart O, Savy M, Obert-Marby C, Mvogo A, Gonzalez A, Trepont A, Cann L, Boceno C, Osei L, Creton PM, Dufit V, Thelusme L, Adenis A, Van-Melle A, Huber F, Nacher M. Hunger in French Guiana's Vulnerable Urban Neighborhoods: A Neglected Consequence of COVID-19. Food Nutr Bull. 2023 Mar;44(1):3-11. doi: 10.1177/03795721231156641. Epub 2023 Feb 23.
PubMed 36824041Nacher M, Basurko C, Muhigirwa GB, Lambert V, Osei L, Njuieyon F, Louis A, Dotou D, Thomas N, Bernard S, Leneuve M, Elenga N, Hcini N. Infant mortality in French Guiana between 2001 and 2017 : Trends and comparisons with mainland France. Rev Epidemiol Sante Publique. 2023 Dec;71(6):102175. doi: 10.1016/j.respe.2023.102175. Epub 2023 Oct 31.
PubMed 37918040
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Insecurity During Pregnancy in French Guiana - Focus on Infant Feeding
- ClinicalTrials.gov ID
- NCT06528275
- Acronym / sponsor ID
- ANJE Nutri / ANJE Nutri
- Conditions
- Food Insecurity, Pregnancy Related
- Keywords
- Infant feeding, Breastfeeding, Food insecurity, Pregnancy, French Guiana
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 30 Jul 2024 (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.
This is a comparative, observal study among the population of pregant women who participated to the study "Nutri Pou Ti Moun" on food insecurity during pregnancy in French Guiana
Detailed description
The international literature has already demonstrated the benefits of breastfeeding (BF) in the short, medium and long term for the health of children and mothers alike. For children, breastfeeding helps to reduce mortality from infections, prevents hospitalisations, particularly for gastroenteritis and respiratory illnesses, and prevents diabetes and childhood obesity. Breastfeeding also plays an important role in children's cognitive development, with an impact on IQ and academic success. For mothers, not breastfeeding is associated with an increased risk of breast and ovarian cancer, type II diabetes, obesity and cardiovascular disorders. Similarly, the WHO recommends optimal feeding practices for infants up to 2 years of age, i.e. early initiation of breastfeeding to allow the child to receive colostrum, exclusive BF for 4 to 6 months, and the timely introduction of liquid, semi-solid or solid foods, the continuation of BF for up to 2 years and beyond, the consumption of age-appropriate infant formula (IF) as an alternative to breastfeeding, and a minimum acceptable intake of complementary food to breast or infant milk.
On a national scale, the 'first 1000 days' initiative (from the 4th month of pregnancy to the child's 2nd birthday) that emerged at the symposium on 23 September 2021 organised by Santé Publique France and the French Ministry of Solidarity and Health includes the objective of promoting good BF practices. Similarly, the 2019-2023 national nutrition and health plan (PNNS4) aims to increase the percentage of children breastfed at birth by at least 15% and to extend the median duration of total breastfeeding by 2 weeks. In French Guyana, the 2023-2028 regional health plan points out that perinatal indicators in the French overseas territories are worse than in mainland France, and that improving mother and child health must involve improving the environment in which children live during their first 1,000 days.
In 2005, an initial retrospective study of breastfeeding practices was carried out in western part of French Guiana and showed a rate of exclusive breastfeeding at 4 months of age of 3% and a rate of continued breastfeeding of 16.7% up to 1 year and 6.5% up to 2 years. Between 2010 and 2012, a prospective survey of the whole of French Guiana found an exclusive BF rate of 27% at 1 month, 9% at 3 months and 5% at 6 months. In the Epifane survey conducted in France between 2010 and 2012, the rate of exclusive breastfeeding at 1 month and 3 months was close to that in French Guiana (28% and 10% respectively), with an average duration of exclusive or predominant breastfeeding of 3 weeks.
The rate of continued breastfeeding for up to 1 year was estimated at 16% in the Guiana study, compared with 9% in France. The rate of mixed breastfeeding concerned 30% of women breastfeeding from the maternity hospital in French Guiana, compared with 20% in France. The main reasons for introducing bottles of infant formula (IF) in both French Guiana and France were the impression of a lack of milk (the child's feeling of dissatisfaction) and the return to work. On the other hand, almost 1 in 2 women in French Guiana stated that no healthcare professional had shown any interest in their breastfeeding at 1 month post-partum.
Since January 2023, the Nutri Pou Ti'moun study ('Nutri 1 project' ID-RCB 2022-A01772-41), carried out in 3 maternity units in French Guiana and involving 800 women who have given birth - the 'Nutri 1 women's group' - aims to take stock of women's food insecurity during pregnancy and to describe the medical consequences observed on the course and outcome of pregnancy and on infant health in the immediate post-partum period. In the course of this project, the links between vitamin and mineral deficiencies, heavy metal impregnation and maternal dietary diversification are being studied. In the Guianese context of multidimensional precariousness, the Guianese perinat network, in partnership with local and institutional players, aimed to set up a health and nutrition pathway from the 4th month of pregnancy in October 2023, comprising weekly workshops co-hosted by a health mediator (on diet, well-being, adapted physical activities and the promotion of breastfeeding) and the distribution of baskets of fresh, local fruit and vegetables.
This health promotion intervention is offered to pregnant women attending the maternal and child health protection centre (PMI) in the Communauté d'agglomération du centre littoral (CACL) - the 'Nutri 2 women's group'. This intervention gave rise to an ancillary research project to the Nutri Pou Ti'moun research project, the Nutri pou ti'moun 2 project (Nutri 2 project; ID-RCB 2023-A00167-38) aimed at assessing the impact of this action on women's diet (diversity and food insecurity) by comparing the data from the Nutri 1 women's group with that from the Nutri 2 women's group. These projects only cover the period from pregnancy to the immediate post-partum period. By 31 December 2023, 786 women had been included in the Nutri 1 project and 57 women in the ancillary Nutri 2 project.
The relevance and interest of conducting research in French Guiana on breastfeeding practices and, more broadly, on infant feeding are justified:
- On the one hand, by the absence of recent published data on infant feeding practices in French Guiana. The second national Epifane survey, to be carried out in 2021 and focusing on infant nutrition during the first year of life, is a study being conducted in parallel with the national perinatal survey in France. An extension of this survey was carried out in the French overseas departments and territories, but French Guiana was not included.
- On the other hand, the Nutri Pou Ti Moun project represents an opportunity to collect data on infant feeding from a representative sample of women giving birth in French Guiana, in the three public maternity hospitals (Nutri 1 group of women). Medical, biomedical and socio-demographic data, as well as data relating to food safety and nutrition during pregnancy already collected during the Nutri Pou Ti moun project, will be analysed with regard to infant feeding practices and child development data (staturo-weight, cranial perimeter, psychomotor development). The impact of a prenatal intervention on nutrition could also be assessed by comparing infant feeding data for children in the Nutri 1 group and those in the Nutri 2 group.
In a socio-economic and health context that is different from that in mainland France, food insecurity in French Guiana during pregnancy, as assessed in the Nutri Pou Ti moun project, is likely to have consequences for young children that it would be relevant to measure and compare with national and international data. In the short term, the impact of this food insecurity would influence the use and duration of breastfeeding, the occurrence of anaemia in young children and dietary practices; and in the medium term, the child's staturo-weight development and cognitive development.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - control | – | –Pregant women included in Nutri Pou Ti Moun 1 project who did not benefit from the health promotion intervention |
| Group 2 - intervention | – | Other: Health promotion interventionPregant women included in Nutri Pou Ti Moun 1 project who benefited from the health promotion intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women living in French Guiana who participated to the Nutri Pou Ti Moun project and who benefited or not from a health promotion intervention on nutrition
Key inclusion criteria (2 listed)
- Intervention group : women included in Nutri Pou Ti Moun project and who benefited from health promotion intervention
- Control group : women included in Nutri Pou Ti Moun project and who did not benefit from health promotion intervention
Key exclusion criteria (4 listed)
- Women refusing to participate to the study
- Women who moved out of French Guiana
- Women lost for follow up or who could not be contacted for the participation to the study
- Minor women who could not obtain authorisation from legal representatives
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 |
|---|---|---|
| Health promotion interventionHealth promotion intervention with activites linked to nutrition, and distribution of baskets of fresh fruits and vegetables | Other | Group 2 - intervention |
Primary outcome
Prevalence of exclusive breastfeeding at 3 months of age in French Guiana
Time frame: At inclusion
To estimate the prevalence of exlusive breastfeeding at 3 months of age in French Guiana in the group control and the group intervention
9 secondary outcomes
Description of exclusive breastfeeding practices
Time frame: At inclusion
Description of artificial breastfeeding practices
Time frame: At inclusion
Description of dietary diversity in infants
Time frame: At inclusion
Description of the minimal dietary diversity
Time frame: 12 months
Description of the minimal dietary diversity of mothers
Time frame: 12 months
Description of staturo-ponderal and psychomotor development indicators
Time frame: 12 months
Breastfeeding rate, exclusive and artificial breastfeeding duration, dietary diversity between groups
Time frame: 12 months
Description of breastfeeding practices from mothers point of view
Time frame: At inclusion
Description of breastfeeding practices from professionals point of view
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 26869575Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
- Background: PubMed 26249674Sankar MJ, Sinha B, Chowdhury R, Bhandari N, Taneja S, Martines J, Bahl R. Optimal breastfeeding practices and infant and child mortality: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):3-13. doi: 10.1111/apa.13147.
- Background: PubMed 26192560Horta BL, Loret de Mola C, Victora CG. Long-term consequences of breastfeeding on cholesterol, obesity, systolic blood pressure and type 2 diabetes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):30-7. doi: 10.1111/apa.13133.
- Background: PubMed 26792873Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
- Background: PubMed 26172878Chowdhury R, Sinha B, Sankar MJ, Taneja S, Bhandari N, Rollins N, Bahl R, Martines J. Breastfeeding and maternal health outcomes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):96-113. doi: 10.1111/apa.13102.
- Background: PubMed 36824041Basurko C, Dupart O, Savy M, Obert-Marby C, Mvogo A, Gonzalez A, Trepont A, Cann L, Boceno C, Osei L, Creton PM, Dufit V, Thelusme L, Adenis A, Van-Melle A, Huber F, Nacher M. Hunger in French Guiana's Vulnerable Urban Neighborhoods: A Neglected Consequence of COVID-19. Food Nutr Bull. 2023 Mar;44(1):3-11. doi: 10.1177/03795721231156641. Epub 2023 Feb 23.
- Background: PubMed 37918040Nacher M, Basurko C, Muhigirwa GB, Lambert V, Osei L, Njuieyon F, Louis A, Dotou D, Thomas N, Bernard S, Leneuve M, Elenga N, Hcini N. Infant mortality in French Guiana between 2001 and 2017 : Trends and comparisons with mainland France. Rev Epidemiol Sante Publique. 2023 Dec;71(6):102175. doi: 10.1016/j.respe.2023.102175. Epub 2023 Oct 31.
- Short-term effects of breastfeeding: a systematic review on the benefits of breastfeeding on diarrhoea and pneumonia mortalityLink provided by the sponsor.
- Indicators for assessing infant and young child feeding practicesLink provided by the sponsor.
- Conference on the "1000 first days" - Santé Publique France - 23 September 2021Link provided by the sponsor.
- French national health and nutrition programLink provided by the sponsor.
- French Guiana Regional Health Program 2018-2028Link provided by the sponsor.
- Duration of breastfeeding period in France - Epifane survey 2012-2013Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Celia BASURKO, MD principal investigator
Centre Hospitalier de Cayenne
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 Food Insecurity and Pregnancy Related, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jul 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 French Guiana. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celia BASURKO, MD (+594 5 94 39 57 66, celia.basurko@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of exclusive breastfeeding at 3 months of age in French Guiana (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06528275, which also lists 7 linked publications.
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 30 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.