Becoming HIV-Exposed, Uninfected Children Born to HIV-Positive Mothers Followed at Bichat Claude Bernard Hospital
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Description of clinical events of interest in children from birth until inclusion in the study (and up to a maximum age of 15 years)
Study Overview
Brief Summary
"The strategies for the Prevention of Mother-to-Child Transmission of the Human Immunodeficiency Virus (HIV) are very effective and have become common practices in many contexts.
Some studies have identified clinical and biological anomalies in a small proportion of infants exposed to antiretrovirals. Beyond 2 years of age, there are few studies with low power describing the long-term consequences of perinatal exposure to antiretrovirals.
It is necessary to understand the impact of antiretroviral treatment during the perinatal period in order to improve the management of children born to HIV-positive mothers.
Retrospective cohort study with interviews of women living with HIV who were followed for a pregnancy in the Infectious diseases department of Bichat-Claude Bernard Hospital, PARIS, France.
After recruitment during a follow-up consultation:
- Information regarding the prenatal and perinatal management of HIV and the infant's outcomes up to 12 months will be collected retrospectively through the medical record
- Information regarding the child's development and follow-up from the age of 1 to a maximum of 15 years will be gathered retrospectively through a self-administered questionnaire or a questionnaire filled out with assistance during a single 1-hour interview with the mother."
Detailed Description
The latest WHO report shows that with 1.3 million (between 970,000 and 1.6 million) HIV-positive pregnant women worldwide in 2020, HIV remains a major global public health issue.
In France, about 2 per 1,000 pregnant women are infected with HIV, resulting in approximately 1,500 births per year over the past fifteen years. The administration of antiretroviral treatment to HIV-positive pregnant women and prophylaxis for infants immediately after birth is the most effective means of preventing mother-to-child transmission (MTCT) of HIV. This risk has been estimated at 0.2% during the period from 2011 to 2017 among women included in the French perinatal survey.
While the number of children infected with HIV is decreasing due to wider access to antiretroviral treatments during pregnancy, the number of HIV-exposed but uninfected children is increasing, raising questions about their long-term outcomes.
Some historical studies have identified clinical and biological anomalies, including lactic acidosis, cardiomyopathy, and neurological anomalies, suggesting mitochondrial dysfunction in a small proportion of uninfected children exposed to antiretrovirals.
Since then, recent studies have provided new evidence suggesting that HIV-exposed but uninfected children, while avoiding vertical transmission of HIV, are at a higher risk of suboptimal health outcomes, including higher rates of severe infectious morbidity, lower early childhood survival, and more frequent occurrences of growth delay and neurological development issues compared to children born without HIV exposure.
Study Design
- Study Type
- Observational
- Observational Model
- Family Based
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Description of clinical events of interest in children from birth until inclusion in the study (and up to a maximum age of 15 years)
Time Frame: 1 day
Clinical events of interest will be collected through a survey from the mother (Eye disorders, Developmental disorders, Language disorders, Hearing disorders, Bone and joint disorders, Cardiac anomalies, Metabolic anomalies (Diabetes, Thyroid, etc.), Pulmonary anomalies, Urinary anomalies, Renal anomalies, Hematological anomalies (sickle cell disease, anemia, etc.))
Secondary Outcomes
- Describe the course of the pregnancy(at inclusion)
- Describe the course of the immediate postpartum period(at inclusion)
- Describe the medical follow-up of children between 0 and 3 years old(at inclusion)
- Describe the medical follow-up of children between 3 and 15 years old(at inclusion)
- Describe the events that occurred in children by age group(at inclusion)
- Describe the events that occurred in children by type of disorders(at inclusion)
- Describe the reasons for non-inclusions(1 day)