Newborn, Infant, DiseaseminiNO-COVIDNCT04952870
Perinatal Covid-19 Infection, NO Pathway, and Minipuberty
An observational study of Newborn, Infant, Disease and Neurodevelopmental Disorders, run by University Hospital, Lille at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Newborn, Infant, Disease, Neurodevelopmental Disorders
- What is being tested?
- Inhaled NO and routine care
- How many people
- 180 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Nov 2022to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Newborn infants at risk for neurodevelopmental disorders
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
France1 site, 1 recruiting
- Recruiting
Hop Jeanne de Flandre Chu Lille
Lille, 59037
0320445962
Greece1 site, 1 recruiting
- Not yet recruiting
Uri-National and Kapodistrian University of Athens
Athens
About this study
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
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
- Being tested
- Inhaled NO, routine care
- Keywords
- Perinatal COVID, newborn, minipuberty, HPG axis, nitric oxide, neurodevelopmental outcome
- Medical subject headings
- Disease, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled NOOther
Newborn or young infants (< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure
routine careOther
Patients treated for respiratory failure
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 group | Perinatal COVID-19 infection group, including newborns born from COVID-19 infected mothers and newborns with postnatal COVID-19 infections; | |
| NO group | Newborns admitted in NICU and receiving inhaled NO for respiratory failure Receives: Other: Inhaled NO | |
| Control group | Newborns admitted in NICU for respiratory failure not receiving iNO and not infected with COVID-19; Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months
Measured: at the postnatal age of 3 months
Secondary outcomes (9)
The change in reproductive hormones
Measured: 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
Measured: 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
Measured: At the postnatal age of 3 months;
Ages and Stages Questionnaire (ASQ-3 ) score
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.
Measured: At the corrected age of 9 and 18 months
Ages and Stages Questionnaire (ASQ-2E) score
Measured: At the corrected age of 9 and 18 months
Bayley-III score
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.
Measured: 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)
Measured: At the corrected age of 9 months
The specific changes in Nos1-associated genes
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start3 Nov 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn, Infant, DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Laurent STORME, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952870
- Sponsor's protocol ID
- 2020_38
- Other IDs
- 2020-A02122-37, grant agreement No 847941
- Acronym
- miniNO-COVID
- Status last verified
- May 2026
- First submitted
- 16 Jun 2021
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04952870
- Acronym / sponsor ID
- miniNO-COVID / 2020_38
- Keywords
- Perinatal COVID, newborn, minipuberty, HPG axis, nitric oxide, neurodevelopmental outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 group | – | –Perinatal COVID-19 infection group, including newborns born from COVID-19 infected mothers and newborns with postnatal COVID-19 infections; |
| NO group | – | Other: Inhaled NONewborns admitted in NICU and receiving inhaled NO for respiratory failure |
| Control group | – | Other: routine careNewborns admitted in NICU for respiratory failure not receiving iNO and not infected with COVID-19; |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn infants at risk for neurodevelopmental disorders
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled NONewborn or young infants (< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure | Other | NO group |
| routine carePatients treated for respiratory failure | Other | Control group |
Primary outcome
The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months
Time frame: at the postnatal age of 3 months
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent STORME, MD,PhD principal investigator
University Hospital, Lille
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn, Infant, Disease and Neurodevelopmental Disorders, run by University Hospital, Lille at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent STORME, MD,PhD (0320445962 ext. +33, laurent.storme@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months (time frame: at the postnatal age of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.