FRESH-PEF73964-en
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
miniNO-COVID
| Name | Country code |
|---|---|
| France | fr |
| Germany | de |
| Switzerland | ch |
| United Kingdom | gb |
| Greece | gr |
| Belgium | be |
['Clinical data','Biological data']
Individuals
| Topic | Vocabulary |
|---|---|
| Endocrinology | health theme |
| Neurology | health theme |
| Paediatrics | health theme |
| Endocrine, nutritional or metabolic diseases | cim-11 |
| Mental, behavioural or neurodevelopmental disorders | cim-11 |
| Diseases of the nervous system | cim-11 |
| COVID-19 | cim-11 |
{
"level_sex_clusion_I": [
{
"value": "Male",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
}
},
{
"value": "Female",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
}
}
],
"level_age_clusion_I": [
{
"value": "Infant, Newborn (birth to 28 days)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D007231"
}
},
{
"value": "Infant (28 days to 2 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D007223"
}
}
],
"level_type_clusion_I": [
"Patients population"
],
"level_type_clusion_other": "",
"clusion_I": "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;",
"clusion_E": ""
}
| Name |
|---|
| Laurent;STORME |
| Vincent;PREVOT |
| Name | Role |
|---|---|
| CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU) | sponsor |
| Name |
|---|
| EUROPEAN COMMISSION RESEARCH |
| Name |
|---|
| European consortium |
['Through independent healthcare practitioners']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access not yet planned
Observational Study
| Start | End |
|---|---|
| 2021-01-01 | 3000-01-01 |
{"value":"Metadata-only access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_14cb"}]}
FRESH-PEF73964-en
| Name | Affiliation |
|---|---|
| Vincent PREVOT | INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) |