Inhaled NO
OtherNewborn or young infants (< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure
NCT Number: NCT04952870
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
Interested in participating?
Request InfoUp to 3 month
All sexes
Observational
Hop Jeanne de Flandre Chu Lille, Lille, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Newborn or young infants (< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure
Patients treated for respiratory failure
Time frame: at the postnatal age of 3 months
Time frame: From the day at inclusion (D0), to Day 2 (48 hours after inclusion), Month 1 and the postnatal age of 3 months
Time frame: From the day at inclusion (D0), to Day 2 (48 hours after inclusion), Month 1 and the postnatal age of 3 months
Time frame: At the postnatal age of 3 months;
Time frame: At the corrected age of 9 and 18 months
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
Time frame: at the corrected age of 9 months of age
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
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.
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.
Contact information is provided by the study sponsor or research team.
University Hospital, Lille
Other
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
Acronym: miniNO-COVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05770999
Disease, Neurologic Manifestations
Kayseri, Turkey (Türkiye)
View Trial DetailsNCT04596202
Comfort, Disease
Çanakkale, Turkey (Türkiye)
View Trial DetailsNCT02423369
Disease, Newborn, Infant, Disease
Kaunas, Lithuania
View Trial DetailsNCT05815095
Autism Spectrum Disorder, Child Development Disorders, Pervasive
Champigny-sur-Marne, France
View Trial Details