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Recruiting NCT04952870

Perinatal Covid-19 Infection, NO Pathway, and Minipuberty

— Observational Newborn, Infant, Disease Neurodevelopmental Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inhaled NO, routine care.
Who it may be relevant to
Registry conditions: Newborn, Infant, Disease, Neurodevelopmental Disorders. Basic parameters: up to 3 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Other Inhaled NO
    Newborn or young infants (\< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure
  • Other routine care
    Patients treated for respiratory failure

Primary outcome measures

  • The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months [Time frame: at the postnatal age of 3 months]
Secondary outcome measures (9)
  • The change in reproductive hormones [Time frame: 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 [Time frame: 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 [Time frame: At the postnatal age of 3 months;]
  • Ages and Stages Questionnaire (ASQ-3 ) score [Time frame: At the corrected age of 9 and 18 months]
  • Ages and Stages Questionnaire (ASQ-2E) score [Time frame: At the corrected age of 9 and 18 months]
  • Bayley-III score [Time frame: at the corrected age of 9 months of age]
  • The time of mutual gaze interactions (versus non-interactive periods) measured by eye-tracking glasses (mother and children) [Time frame: At the corrected age of 9 months]
  • The specific changes in Nos1-associated genes [Time frame: From the day at inclusion (D0), Day 2, 1 month and 3 months of age and in buccal cells collected at the postnatal age of 3 months of age.]
  • The specific changes in miRNAs in blood sampled [Time frame: From the day at inclusion (D0), Day 2, 1 month and 3 months of age and in buccal cells collected at the postnatal age of 3 months of age.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Hop Jeanne de Flandre Chu Lille — Lille
Greece · 1 center
  • Uri-National and Kapodistrian University of Athens — Athens

Identifiers

NCT: NCT04952870 · 2020_38 · 2020-A02122-37 · grant agreement No 847941

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗