Perinatal Covid-19 Infection, NO Pathway, and Minipuberty

NCT ID: NCT04952870

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2026-11-30

Brief Summary

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

Conditions

Newborn, Infant, Disease; Neurodevelopmental Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 group

Perinatal COVID-19 infection group, including newborns born from COVID-19 infected mothers and newborns with postnatal COVID-19 infections;

No interventions assigned to this group

NO group

Newborns admitted in NICU and receiving inhaled NO for respiratory failure

Inhaled NO

Intervention Type: OTHER

Newborn or young infants (\< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure

Control group

Newborns admitted in NICU for respiratory failure not receiving iNO and not infected with COVID-19;

routine care

Intervention Type: OTHER

Patients treated for respiratory failure

Interventions

Inhaled NO

Newborn or young infants (\< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure

Intervention Type: OTHER

routine care

Patients treated for respiratory failure

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent STORME, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status: RECRUITING

Uri-National and Kapodistrian University of Athens

Athens, , Greece

Site Status: NOT_YET_RECRUITING

Countries

France; Greece

Central Contacts

Laurent STORME, MD,PhD

Role: CONTACT

laurent.storme@chru-lille.fr

0320445962 ext. +33

Facility Contacts

Role: primary

0320445962

Other Identifiers

2020-A02122-37

Identifier Type: OTHER

Identifier Source: secondary_id

grant agreement No 847941

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2020_38

Identifier Type: -

Identifier Source: org_study_id