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NCT Number: NCT04952870

Perinatal Covid-19 Infection, NO Pathway, and Minipuberty

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

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Key information

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled NO

Other

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

Routine care

Other

Patients treated for respiratory failure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Rate of negative hearing and olfactive tests

    Time frame: At the postnatal age of 3 months;

  4. Ages and Stages Questionnaire (ASQ-3 ) score

    Time frame: At the corrected age of 9 and 18 months

    The ASQ-3 is a questionnaire aimed to pinpoint developmental progress in children between 1 month to 5.5 years in age. It is parent-centric and is administered through paper and pencil. It takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-3 scores of FNI and non-FNI participants by measuring across five developmental areas: communication, gross motor, fine motor, problem solving, and personal-social.

  5. Ages and Stages Questionnaire (ASQ-2E) score

    Time frame: At the corrected age of 9 and 18 months

  6. Bayley-III score

    Time frame: at the corrected age of 9 months of age

    The Bayley Scale of Infant and Toddler Development, Third Edition (Bayley III) measures physical, motor, sensory, and cognitive development in babies and young children. The scale encompasses five developmental domains - cognitive, language, motor, social-emotional and adaptive behaviour. The structure of the Bayley-III Scales allows clinicians to administer each of the five scales (cognitive, language-receptive and expressive, motor-fine and gross, social-emotional, and adaptive behaviour) independent of others. Higher scores in each scale indicates more advanced development. Performance is summarised via scaled scores for each subtest, and composite scores for each scale, together with percentile ranks, developmental age equivalents, and growth scores. Discrepancy information is used to determine whether there are significant differences between a child's abilities in the domains measured, and how prevalent these differences are in the norming sample. A total score is not provided.

  7. 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

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent STORME, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • European Commission

Registry information

Official study 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

Acronym: miniNO-COVID

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2021
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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