Perinatal Covid-19 Infection, NO Pathway, and Minipuberty (miniNO-COVID)

University Hospital, Lille

Status

Enrolling

Conditions

Neurodevelopmental Disorders

Newborn, Infant, Disease

Treatments

Other: routine care

Other: Inhaled NO

Study type

Observational

Funder types

Other

Identifiers

NCT04952870

2020-A02122-37 (Other Identifier)

grant agreement No 847941 (Other Grant/Funding Number)

2020_38

Details and patient eligibility

About

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

Enrollment

180 estimated patients

Sex

All

Ages

Under 3 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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