ITMO public health
Last update : 02/12/2021 | Version : 1 | ID : 73964
| General | |
| Identification | |
| Detailed name | 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 |
| Sign or acronym | miniNO-COVID |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | 2020-A02122-37 |
| General Aspects | |
| Medical area |
Biology Endocrinology and metabolism Neurology Pediatrics |
| Study in connection with Covid-19 |
Yes |
| Scientific investigator(s) (Contact) | |
| Name of the director | STORME |
| Surname | Laurent |
| Address |
Hôpital Jeanne de Flandre, CHU Lille Avenue Eugène Avinée, 59037 LILLE CEDEX |
| Unit | Neonatal Intensive Care Unit of the CHU of Lille; FHU 1000 days for health |
| Organization | CHU Lille |
| Name of the director | PREVOT |
| Surname | Vincent |
| Address |
Inserm U1172 Bâtiment Biserte 1 place de Verdun 59045 Lille Cedex |
| Phone | +33 §12 90 38 76 |
| Unit | Laboratory of Development and Plasticity of the Neuroendocrine Brain; Lille Neuroscience & Cognition; FHU 1000 days for health |
| Organization | Inserm, Univ. Lille, CHU Lille |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | European consortium |
| Funding | |
| Funding status |
Public |
| Details | European Union’s Horizon 2020 research and innovation program under grant agreement No 847941 (miniNO) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU LIlle |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Labelling and database evaluation | miniNO council members |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control study |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | 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 |
| Inclusion criteria |
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; |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) |
| Population covered |
Sick population |
| Pathology | IV - Endocrine, nutritional and metabolic diseases |
| V - Mental and behavioural disorders | |
| VI - Diseases of the nervous system | |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | France, Germany, Switzerland, UK, Belgium and Greece |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | Fevrier 2021 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | 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 |
| Biological data (detail) | 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) |
| Presence of a biobank |
No |
| Procedures | |
| Data collection method | 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. |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by convocation of the participant |
| Details on monitoring of participants | 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 |
| Followed pathology | V - Mental and behavioural disorders |
| IV - Endocrine, nutritional and metabolic diseases | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://www.minino-project.com |
| Access to aggregated data |
Access not yet planned |
| Access to individual data |
No access |
| ABOUT | CATALOG | RESOURCES | USEFUL LINKS |
This site complies with the HONcode standard for trustworthy health information: |
8 rue de la Croix Jarry 75013 Paris Phone : +33 1 44 23 67 47 |
Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05
