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
This trial does not accept healthy volunteersQualifiers
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 population
Newborn infants at risk for neurodevelopmental disorders
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Inhaled NO
Other interventionNewborn or young infants (\< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure
routine care
Other interventionPatients treated for respiratory failure
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: COVID-19 group0 interventions
Group B: NO group1 intervention
Group C: Control group1 intervention
Trial outcomes
Primary outcomes
1
The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months
Time frame
at the postnatal age of 3 monthsSecondary outcomes
1
The change in reproductive hormones
Time frame
From the day at inclusion (D0), to Day 2 (48 hours after inclusion), Month 1 and the postnatal age of 3 months2
The change in metabolic hormones
Time frame
From the day at inclusion (D0), to Day 2 (48 hours after inclusion), Month 1 and the postnatal age of 3 months3
Rate of negative hearing and olfactive tests
Time frame
At the postnatal age of 3 months;4
Ages and Stages Questionnaire (ASQ-3 ) score
The ASQ-3 is a questionnaire aimed to pinpoint developmental progress in children between 1 month to 5.5 years in age. It is parent-centric and is administered through paper and pencil. It takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-3 scores of FNI and non-FNI participants by measuring across five developmental areas: communication, gross motor, fine motor, problem solving, and personal-social.
Time frame
At the corrected age of 9 and 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
European Commission
Collaborator
Source ClinicalTrials.gov