Perinatal Covid-19 Infection, NO Pathway, and Minipuberty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 3
SponsorUniversity Hospital, Lille
About this trial
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 criteria
Qualifiers
Antenatal COVID-19 infection: pregnant women with positive PCR test at any time of the pregnancy;
Post-natal COVID-19 infection: newborn or young infants (< 3 months) with positive PCR test in pharynx or stools as part of their treatment.
Group 2 : Newborn infants (24 to 41 weeks gestational age) or young infants (< 3 months) admitted at the maternity ward or at the Department of Neonatology at Jeanne de Flandre Hospital, CHU of Lille for severe cardiorespiratory diseases requiring inhaled NO treatment.
Group 3 : The control group without perinatal COVID-19 infection and no inhaled NO treatment will be matched to the two other groups on age at birth (± 2 weeks of gestation), on postnatal age (± 3 weeks), on respiratory failure (yes/no).
Disqualifiers
Preterm birth less than 24 weeks gestational age.
Severe brain lesions: bilateral and extensive periventricular leukomalacia, intracranial hemorrhage grade 3 or 4;
One or both of the parents is unable to read or understand French language, or refuse to participate
Trial design
Treatments tested in this trial
- Inhaled NO
- routine care
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
University Hospital, Lille
Lead sponsor
European Commission
Collaborator
Source ClinicalTrials.gov