An observational study in Newborn, Infant, Disease and Neurodevelopmental Disorders, sponsored by University Hospital, Lille. Recruiting at 2 sites in 2 countries. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by University Hospital, Lille · Observational
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
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's planned enrollment of 180 is close to the median of 200 across 133 observational studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
Compared within Neurodevelopmental Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Newborn infants at risk for neurodevelopmental disorders
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group 1 : 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 with perinatal COVID-19 infection defined by:
Exclusion Criteria:
Perinatal COVID-19 infection group, including newborns born from COVID-19 infected mothers and newborns with postnatal COVID-19 infections;
Newborns admitted in NICU and receiving inhaled NO for respiratory failure
Other: Inhaled NO
Newborns admitted in NICU for respiratory failure not receiving iNO and not infected with COVID-19;
Other: routine care
Newborn or young infants (\< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure
Patients treated for respiratory failure
The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months
Time frame: at the postnatal age of 3 months
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 months
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 months
Rate of negative hearing and olfactive tests
Time frame: At the postnatal age of 3 months;
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 months
Ages and Stages Questionnaire (ASQ-2E) score
Time frame: At the corrected age of 9 and 18 months
Bayley-III score
The Bayley Scale of Infant and Toddler Development, Third Edition (Bayley III) measures physical, motor, sensory, and cognitive development in babies and young children. The scale encompasses five developmental domains - cognitive, language, motor, social-emotional and adaptive behaviour. The structure of the Bayley-III Scales allows clinicians to administer each of the five scales (cognitive, language-receptive and expressive, motor-fine and gross, social-emotional, and adaptive behaviour) independent of others. Higher scores in each scale indicates more advanced development. Performance is summarised via scaled scores for each subtest, and composite scores for each scale, together with percentile ranks, developmental age equivalents, and growth scores. Discrepancy information is used to determine whether there are significant differences between a child's abilities in the domains measured, and how prevalent these differences are in the norming sample. A total score is not provided.
Time frame: at the corrected age of 9 months of age
The time of mutual gaze interactions (versus non-interactive periods) measured by eye-tracking glasses (mother and children)
Time frame: At the corrected age of 9 months
The specific changes in Nos1-associated genes
Time frame: From the day at inclusion (D0), Day 2, 1 month and 3 months of age and in buccal cells collected at the postnatal age of 3 months of age.
The specific changes in miRNAs in blood sampled
Time frame: From the day at inclusion (D0), Day 2, 1 month and 3 months of age and in buccal cells collected at the postnatal age of 3 months of age.
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Neurodevelopmental Disorders →