Impact of perinatal COVID-19 on infant development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the potential effects of perinatal COVID-19 infection on the maturation of the Hypothalamic-Pituitary-Gonadal (HPG) axis during a critical period known as minipuberty. It aims to determine whether alterations in this hormonal axis could be linked to long-term neurodevelopmental disorders in infants. The study will include newborns and young infants with confirmed COVID-19 infections, as well as a control group without such infections, to assess differences in development. Inhaled nitric oxide may be used as part of the routine care for some participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Hop Jeanne de Flandre Chu Lille
  Lille, France Recruiting
• Uri-National and Kapodistrian University of Athens
  Athens, Greece Not yet recruiting

Study contacts

• Principal investigator: Laurent STORME, MD,PhD — University Hospital, Lille
• Study coordinator: Laurent STORME, MD,PhD
• Email: laurent.storme@chru-lille.fr
• Phone: 0320445962

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.