Impact of perinatal COVID-19 on infant development

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

This study looks at how COVID-19 infection during pregnancy might affect the development of newborns' hormones and whether this could lead to long-term developmental issues.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: N/A to 3 Months
• Sex: All
• Sponsor: University Hospital, Lille (other)
• Locations: 2 sites (Lille and 1 other locations)
• Trial ID: NCT04952870 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include newborns and young infants (up to 3 months old) with confirmed perinatal COVID-19 infection or those requiring inhaled nitric oxide treatment.

Not a fit: Patients who are older than 3 months or do not have perinatal COVID-19 infection are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how perinatal COVID-19 affects infant hormonal development and long-term health outcomes.

How similar studies have performed: While the specific focus on perinatal COVID-19 and its impact on minipuberty is novel, related studies on the effects of viral infections on neurodevelopment have shown varying degrees of success.

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

Where this trial is running

Lille and 1 other locations

• 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

Conditions: Newborn, Infant, Disease, Neurodevelopmental Disorders, Perinatal COVID, newborn, minipuberty, HPG axis, nitric oxide, neurodevelopmental outcome