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COVID-19 in newborns: could it alter key hormone pathways?

NCT ID NCT04952870

Knowledge-focused Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 180 infants who had COVID-19 around birth to see if the infection affects hormone levels and development. Researchers focus on a temporary hormone surge called minipuberty, which is important for growth. By measuring hormones and developmental milestones, they hope to understand long-term effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how COVID-19 around birth affects infant development, pointing to ways to monitor or support at-risk children.
What could go wrong
This is an observational study, not a treatment trial. It is exploratory and may not find clear links. Results may not apply to all infants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Newborn infants at risk for neurodevelopmental disorders

Ages

Up to 3 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

disease neurodevelopmental disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurodevelopmental disorders Newborn, infant, disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hop Jeanne de Flandre Chu Lille

    RECRUITING

    Lille, 59037, France

  • Uri-National and Kapodistrian University of Athens

    NOT_YET_RECRUITING

    Athens, Greece

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