Идёт набор NCT04952870

Perinatal Covid-19 Infection, NO Pathway, and Minipuberty

— Наблюдательное Newborn, Infant, Disease Neurodevelopmental Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Inhaled NO, routine care.
Кому может быть актуально: Состояния в реестре: Newborn, Infant, Disease, Neurodevelopmental Disorders. Базовые параметры: до 3 мес. · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция, Греция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Вмешательства

Другое Inhaled NO
Newborn or young infants (\< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure
Другое routine care
Patients treated for respiratory failure

Первичные конечные точки

The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months [Срок оценки: at the postnatal age of 3 months]

Вторичные конечные точки (9)

The change in reproductive hormones [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At the postnatal age of 3 months;]
Ages and Stages Questionnaire (ASQ-3 ) score [Срок оценки: At the corrected age of 9 and 18 months]
Ages and Stages Questionnaire (ASQ-2E) score [Срок оценки: At the corrected age of 9 and 18 months]
Bayley-III score [Срок оценки: 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) [Срок оценки: At the corrected age of 9 months]
The specific changes in Nos1-associated genes [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

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:

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).
No inclusion in another ante- or post-natal trial;
Written consents from both parents.
Social security affiliation

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет