Perinatal Covid-19 Infection, NO Pathway, and Minipuberty

NCT04952870 | Recruiting DMC

• 3 other identifiers: 2020_382020-A02122-37grant agreement No 847941
• Study Type: observational
• Target: 180
• Locations: 2 countries
• Sites: 2

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

Keywords

Perinatal COVID; newborn; minipuberty; HPG axis; nitric oxide; neurodevelopmental outcome

Outcome Measures

Primary Outcomes (1)

• The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months

  at the postnatal age of 3 months

Secondary Outcomes (9)

• The change in reproductive hormones

  From the day at inclusion (D0), to Day 2 (48 hours after inclusion), Month 1 and the postnatal age of 3 months

• The change in metabolic hormones

  From the day at inclusion (D0), to Day 2 (48 hours after inclusion), Month 1 and the postnatal age of 3 months

• Rate of negative hearing and olfactive tests

  At the postnatal age of 3 months;

• Ages and Stages Questionnaire (ASQ-3 ) score

  At the corrected age of 9 and 18 months

• Ages and Stages Questionnaire (ASQ-2E) score

  At the corrected age of 9 and 18 months

Study Arms (3)

COVID-19 group

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

NO group

Newborns admitted in NICU and receiving inhaled NO for respiratory failure

Other: Inhaled NO

Control group

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

Other: routine care

Interventions

Inhaled NO OTHER

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

NO group

routine care OTHER

Patients treated for respiratory failure

Control group

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn infants at risk for neurodevelopmental disorders

You may qualify if:

• 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).
• Written consents from both parents.
• Social security affiliation

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• European Commission: collaborator

Study Sites (2)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

RECRUITING

Uri-National and Kapodistrian University of Athens

Athens, Greece

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood for Genetic analysis Urine for nitrite/nitrates and hormones; Living buccal cells for mRNA

MeSH Terms

Conditions

Disease; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Laurent STORME, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent STORME, MD,PhD

CONTACT

0320445962; laurent.storme@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 7, 2021
• Study Start: November 3, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

GR (1); FR (1)