Actively Recruiting

Age: 0 - 3Months
All Genders
NCT04952870

Perinatal Covid-19 Infection, NO Pathway, and Minipuberty

Led by University Hospital, Lille · Updated on 2023-02-08

180

Participants Needed

2

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

E

European Commission

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Perinatal Covid-19 Infection, NO Pathway, and Minipuberty

Who Can Participate

Age: 0 - 3Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborn infants born between 24 and 41 weeks gestation or young infants younger than 3 months admitted to the maternity ward or neonatal department
  • Group 1: Infants with perinatal COVID-19 infection shown by positive PCR in the mother during pregnancy or in the infant after birth
  • Group 2: Infants with severe cardiorespiratory disease requiring inhaled nitric oxide treatment
  • Group 3: Control infants without COVID-19 infection or inhaled nitric oxide treatment, matched by birth age, postnatal age, and respiratory failure status
  • No participation in another ante- or post-natal trial
  • Written consent obtained from both parents
  • Social security affiliation
Not Eligible

You will not qualify if you...

  • Birth before 24 weeks gestation
  • Severe brain injuries such as extensive periventricular leukomalacia or grade 3 or 4 intracranial hemorrhage
  • One or both parents unable to read or understand French or who refuse to participate

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hop Jeanne de Flandre Chu Lille

Lille, France, 59037

Actively Recruiting

2

Uri-National and Kapodistrian University of Athens

Athens, Greece

Not Yet Recruiting

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Research Team

L

Laurent STORME, MD,PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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