ITMO Santé Publique
ITMO Santé Publique
Date de modification : 12/02/2021 | Version : 1 | ID : 73964
| Général | |
| Identification | |
| Nom détaillé | 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 |
| Sigle ou acronyme | miniNO-COVID |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | 2020-A02122-37 |
| Thématiques générales | |
| Domaine médical |
Biology Endocrinology and metabolism Neurology Pediatrics |
| Etude en lien avec la Covid-19 |
Yes |
| Responsable(s) scientifique(s) | |
| Nom du responsable | STORME |
| Prénom | Laurent |
| Adresse |
Hôpital Jeanne de Flandre, CHU Lille Avenue Eugène Avinée, 59037 LILLE CEDEX |
| Laboratoire | Neonatal Intensive Care Unit of the CHU of Lille; FHU 1000 days for health |
| Organisme | CHU Lille |
| Nom du responsable | PREVOT |
| Prénom | Vincent |
| Adresse |
Inserm U1172 Bâtiment Biserte 1 place de Verdun 59045 Lille Cedex |
| Téléphone | +33 §12 90 38 76 |
| Laboratoire | Laboratory of Development and Plasticity of the Neuroendocrine Brain; Lille Neuroscience & Cognition; FHU 1000 days for health |
| Organisme | Inserm, Univ. Lille, CHU Lille |
| Collaborations | |
| Participation à des projets, des réseaux, des consortiums |
Yes |
| Précisions | European consortium |
| Financements | |
| Financements |
Public |
| Précisions | European Union’s Horizon 2020 research and innovation program under grant agreement No 847941 (miniNO) |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | CHU LIlle |
| Statut de l’organisation |
Secteur Public |
| Existence de comités scientifique ou de pilotage |
Yes |
| Labellisations et évaluations de la base de données | miniNO council members |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Case control study |
| Origine du recrutement des participants |
A selection of health care professionals |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Objectif de la base de données | |
| Objectif principal | To compare the follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months between the three matched (on gestational age at birth, postnatal age and respiratory failure) newborn infants groups |
| Critères d'inclusion |
o 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:
o Antenatal COVID-19 infection: pregnant women with positive PCR test at any time of the pregnancy; o Post-natal COVID-19 infection: newborn or young infants (< 3 months) with positive PCR test in pharynx or stools as part of their treatment. o 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. o The control group without perinatal COVID-19 infection will be matched to thevtreatment group on gestational age at birth (± 2 weeks of gestation), on postnatal age (± 3 weeks) and respiratory failure. o No inclusion in another ante- or post-natal trial; o Written consents from both parents; |
| Type de population | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) |
| Population concernée |
Sick population |
| Pathologie | IV - Endocrine, nutritional and metabolic diseases |
| V - Mental and behavioural disorders | |
| VI - Diseases of the nervous system | |
| Sexe |
Male Woman |
| Champ géographique |
International |
| Détail du champ géographique | France, Germany, Switzerland, UK, Belgium and Greece |
| Collecte | |
| Dates | |
| Année du premier recueil | Fevrier 2021 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Données | |
| Activité de la base |
Current data collection |
| Type de données recueillies |
Clinical data Biological data |
| Données cliniques, précisions |
Direct physical measures Medical registration |
| Détail des données cliniques recueillies | Clinical examination, body weight, size, vital signals; Clinical examination; Hearing evaluation Olfactive assessement; Brain-to-brain dyad synchrony; ASQ-3 and ASQ-SE assessment; Bayley scale - III |
| Données biologiques, précisions | FSH/LH plasma concentration; Hormonal test (blood sampling) - Estrogen (females) - Testosterone (males) - AMH (females) - PSA (males); Metabolite assessment (blood sampling) - Glucose, - Insulin, - Leptin, - Nitrates in urine sample; Genetic counseling (blood sampling for genetic and epigenetic screening) |
| Existence d’une biothèque |
No |
| Modalités | |
| Mode de recueil des données | Once the patient is included in the study, an investigator manually collects demographic data, as well as data related to the intervention. This collection is pseudonymized: only the first letter of the name and the first letter of the first name appear on the collection sheet. |
| Suivi des participants |
Yes |
| Modalités de suivi des participants |
Monitoring by convocation of the participant |
| Détail du suivi | At Corrected age of 9 month: - Clinical examination and cardiovascular assessment; - Blood sampling (2 ml) for the measurement of reproductive hormones and sampling for miRNA screening; - ASQ-3 and ASQ-SE-2 assessment by the parents; - Bayley – III assessment; - Measure of the brain-to-brain synchrony in the mother-baby dyad in different social contexts (mutual-gaze vs non-interactive periods). We will also focus on social cognition, since this cognitive domain is regularly impaired in neurodevelopemental disorders (including autism). In this context, we will not only explore the child development and ability but consider the dyadic system gathering the child and her/his mother. We will assess mother-child interactions at 9 months of corrected age looking at brain-to-brain synchrony between these two partners. We will focus on two distinct periods: mutual gaze interactions versus non-interactive periods and refer to two ecological and non-invasive systems dedicated to these measures: 2x eye-tracking glasses and 2x high-density EEG systems (electroencephalography) for the child and her/his mother. At the age of 18 months: ASQ-3 and ASQ-SE-2 assessment by the parents |
| Pathologie suivies | V - Mental and behavioural disorders |
| IV - Endocrine, nutritional and metabolic diseases | |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Accès | |
| Site internet dédié | https://www.minino-project.com |
| Accès aux données agrégées |
Access not yet planned |
| Accès aux données individuelles |
No access |
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