RecruitingNCT04952870

Perinatal Covid-19 Infection, NO Pathway, and Minipuberty

Exploratory Multicenter Observational Study to Assess the Outcome of Infants With Perinatal SARS-COV-2 Infection and Its Link With the NO Pathway: the Minipuberty Hypothesis

Sponsor

University Hospital, Lille

Enrollment

180 participants

Start Date

Nov 3, 2022

Study Type

OBSERVATIONAL

Conditions

Neurodevelopmental Disorders Newborn, Infant, Disease

Summary

Some evidence exists that SARS-COV-2 may infect pituitary axis, and therefore may alter hypothalamic function. Whether perinatal COVID-19 is associated with alterations in the maturation of the Hypothalamic-Pituitary-Gonadal (HPG) axis, and specifically with its transient activation occurring during infancy, namely minipuberty, is a major concern. Among the various pathogenic features related to COVID-19, altered minipuberty could be a key factor underlying many multimorbidities later in life, suggesting that they could involve a common causative mechanism that occurs within this short and critical period of time following birth. Altered minipuberty together with NO deficiency seem to be key factors underlying many of these multimorbidities, suggesting that they involve a common causative mechanism that occurs within this short and critical period of time following birth

Eligibility

Max Age: 3 Months

Plain Language Summary

Simplified for easier understanding

This study looks at how COVID-19 infection around the time of birth affects hormone development in newborns and very young infants, particularly a natural hormonal process called 'minipuberty' that happens in the first few months of life. The study also looks at a related group of babies who needed inhaled nitric oxide (NO) treatment for heart or breathing problems. Understanding any disruption to these early hormonal signals may help doctors care for babies who were exposed to COVID-19 at birth. You may be eligible if (your baby): - Is a newborn or infant under 3 months old - Is admitted to Jeanne de Flandre Hospital in Lille, France - Had COVID-19 exposure during pregnancy (mother tested positive) or as a newborn/young infant - OR needs inhaled nitric oxide (NO) for a serious cardiorespiratory condition - Parents can provide written consent - Family has French social security coverage You may NOT be eligible if (your baby): - Was born before 24 weeks of pregnancy - Has severe brain injury (grade 3–4 hemorrhage or extensive white matter damage) - Parents cannot read or understand French, or refuse to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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