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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months
时间窗: at the postnatal age of 3 months
次要结局
- The change in metabolic hormones(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(At the postnatal age of 3 months;)
- Ages and Stages Questionnaire (ASQ-2E) score(At the corrected age of 9 and 18 months)
- Bayley-III score(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)(At the corrected age of 9 months)
- The specific changes in Nos1-associated genes(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(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 change in reproductive hormones(From the day at inclusion (D0), to Day 2 (48 hours after inclusion), Month 1 and the postnatal age of 3 months)
- Ages and Stages Questionnaire (ASQ-3 ) score(At the corrected age of 9 and 18 months)