PrematurityminiNONCT04914806
Infantile NO Replenishment as a New Therapeutic Possibility
An observational study of Prematurity and Respiratory Distress Syndrome, Newborn, run by National and Kapodistrian University of Athens at 3 sites in 3 countries.
Trial summary
Case-control study of inhaled Nitric Oxide (iNO) treatment of full-term and preterm infants. The main objective of this study is to investigate the association between premature birth and its later comorbidities (neuroendocrine, metabolic, cognitive, etc) with iNO treatment and the maturation of the HPG axis during… Read more about this study
- Who is it for?
- Ages 1 day to 3 weeks
- Conditions the study is for
- Prematurity, Respiratory Distress Syndrome, Newborn
- How many people
- 240 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jun 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 3 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm and full-term infants admitted to the Neonatal Unit due to respiratory distress.
Who may be able to join
- Preterm (GA<37 weeks) or full-term (≥37 weeks of gestation) infants
- Requiring respiratory support
- Admitted to Neonatal Care Unit
Who cannot join
- Severe congenital anomalies
- Suspected major chromosomal anomalies
- Infants judged by the physician as nonviable
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
France1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Regional Et Universitaire de Lille
Lille, 59037
Laurent Storme, Professor
Greece1 site, 1 recruiting
- Recruiting
URI-NKUA
Athens, 11527
George Chrousos, Professor, +302107795553, chrousos@gmail.com
Tania Siahanidou, Professor, +302132013517, siahan@med.uoa.gr
Switzerland1 site
- Active, not recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1005
About this study
Official title: Association Between Premature Birth and Its Comorbidities With NO and the HPG Activation at Minipuberty
Case-control study of inhaled Nitric Oxide (iNO) treatment of full-term and preterm infants. The main objective of this study is to investigate the association between premature birth and its later comorbidities (neuroendocrine, metabolic, cognitive, etc) with iNO treatment and the maturation of the HPG axis during minipuberty.
Read the detailed description
In preterm infants, inhaled NO (iNO) is routinely used to treat respiratory failure and pulmonary hypertension, while preclinical studies have shown that it markedly increases NO concentrations in the brain. Animal and human studies have shown that NO deficiency may jeopardize the establishment of a mature and functional HPG axis whereas it is also associated with a series of comorbidities affecting the overall brain development (e.g. sensory, fertility and cognitive functions). Prematurity has been associated with a series of non-communicable diseases of major importance in public health, including neurodevelopmental impairments, metabolic abnormalities (e.g. obesity, type 2 diabetes mellitus, impaired glucose tolerance) and cardiovascular disease. This study aims to evaluate the associations between altered minipuberty in preterm infants and the later development of multi-comorbidities (mental and non-mental disorders), and identify the possible implication of the NO pathway as a causative mechanism.
Specific objectives :
- Assess the efficiency of NO replenishment therapy (i.e. role of NO pathway) as a therapeutic against alterations of minipuberty resulting from preterm birth.
- Assess the efficiency of NO replenishment therapy (i.e. role of NO pathway) as a therapeutic against the multi-comorbidities (mental and non-mental disorders) related to altered minipuberty as a result of preterm birth.
- Keywords
- preterm birth, neurodevelopment, cardiometabolic, minipuberty
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Infants treated with iNO (from birth to 1-3 weeks of life) or sequential treatment with iNO and sildenafil (for 1 to 3 months). | |
| Controls | Infants matched to cases (gestational/postnatal age, gender, disease state) and no iNO treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gonadotrophin levels
Serial blood levels of gonadotrophins (FSH and LH)
Measured: up to 9 months of age
Body fat and fat-free mass
Serial fat and fat-free mass measurements by air displacement plethysmography
Measured: up to 9 months of age
HOMA-IR
Serial measurements of blood glucose/insulin (HOMA-IR)
Measured: up to 9 months
Bayleys scale score
The Bayley Scales of Infant and Toddler Development will be used to assess neurodevelopment. Values <85 indicate developmental delay.
Measured: at 9 months of age
Secondary outcomes (4)
Otoacoustic emissions
Serial otoacoustic emissions as a screening test for hearing ability
Measured: up to 9 months
Fundoscopy
Ophthalmological follow-up for retina and visual assessment
Measured: up to 9 months
gusto-facial reflex
Assessment of olfaction will be performed using a citrus, vanilla or neutral odor, delivered on a cotton swab. The facial expressions in reaction to the different smells (the gusto-facial reflex) will be monitored while at rest (baseline), and in response to stimuli.
Measured: at 3 and 9 months of age
Leptin levels
Serial measurements of serum leptin levels
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- URI-NKUA, University Hospital, Lille, Centre Hospitalier Universitaire Vaudois, European Commission
- Responsible party
- Principal investigator, Soultana (Tania) Siahanidou, National and Kapodistrian University of Athens
- Investigators
- George P. Chrousos, Professor, Study chair, URI-NKUA, Athens, Greece, 11527
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914806
- Sponsor's protocol ID
- miniNO
- Acronym
- miniNO
- Status last verified
- Dec 2022
- First submitted
- 27 May 2021
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Premature Birth and Its Comorbidities With NO and the HPG Activation at Minipuberty
- ClinicalTrials.gov ID
- NCT04914806
- Acronym / sponsor ID
- miniNO / miniNO
- Keywords
- preterm birth, neurodevelopment, cardiometabolic, minipuberty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- URI-NKUA, University Hospital, Lille, Centre Hospitalier Universitaire Vaudois, European Commission
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jun 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.
Case-control study of inhaled Nitric Oxide (iNO) treatment of full-term and preterm infants. The main objective of this study is to investigate the association between premature birth and its later comorbidities (neuroendocrine, metabolic, cognitive, etc) with iNO treatment and the maturation of the HPG axis during minipuberty.
Detailed description
In preterm infants, inhaled NO (iNO) is routinely used to treat respiratory failure and pulmonary hypertension, while preclinical studies have shown that it markedly increases NO concentrations in the brain. Animal and human studies have shown that NO deficiency may jeopardize the establishment of a mature and functional HPG axis whereas it is also associated with a series of comorbidities affecting the overall brain development (e.g. sensory, fertility and cognitive functions). Prematurity has been associated with a series of non-communicable diseases of major importance in public health, including neurodevelopmental impairments, metabolic abnormalities (e.g. obesity, type 2 diabetes mellitus, impaired glucose tolerance) and cardiovascular disease. This study aims to evaluate the associations between altered minipuberty in preterm infants and the later development of multi-comorbidities (mental and non-mental disorders), and identify the possible implication of the NO pathway as a causative mechanism.
Specific objectives :
- Assess the efficiency of NO replenishment therapy (i.e. role of NO pathway) as a therapeutic against alterations of minipuberty resulting from preterm birth.
- Assess the efficiency of NO replenishment therapy (i.e. role of NO pathway) as a therapeutic against the multi-comorbidities (mental and non-mental disorders) related to altered minipuberty as a result of preterm birth.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Infants treated with iNO (from birth to 1-3 weeks of life) or sequential treatment with iNO and sildenafil (for 1 to 3 months). |
| Controls | – | –Infants matched to cases (gestational/postnatal age, gender, disease state) and no iNO treatment. |
Who may qualify
- Ages
- 1 day to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm and full-term infants admitted to the Neonatal Unit due to respiratory distress.
Key inclusion criteria (3 listed)
- Preterm (GA<37 weeks) or full-term (≥37 weeks of gestation) infants
- Requiring respiratory support
- Admitted to Neonatal Care Unit
Key exclusion criteria (3 listed)
- Severe congenital anomalies
- Suspected major chromosomal anomalies
- Infants judged by the physician as nonviable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gonadotrophin levels
Time frame: up to 9 months of age
Serial blood levels of gonadotrophins (FSH and LH)
Body fat and fat-free mass
Time frame: up to 9 months of age
Serial fat and fat-free mass measurements by air displacement plethysmography
HOMA-IR
Time frame: up to 9 months
Serial measurements of blood glucose/insulin (HOMA-IR)
Bayleys scale score
Time frame: at 9 months of age
The Bayley Scales of Infant and Toddler Development will be used to assess neurodevelopment. Values <85 indicate developmental delay.
4 secondary outcomes
Otoacoustic emissions
Time frame: up to 9 months
Fundoscopy
Time frame: up to 9 months
gusto-facial reflex
Time frame: at 3 and 9 months of age
Leptin levels
Time frame: up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
George P. Chrousos, Professor study chair
URI-NKUA, Athens, Greece, 11527
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity and Respiratory Distress Syndrome, Newborn, run by National and Kapodistrian University of Athens at 3 sites in 3 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 3 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Greece, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George P. Chrousos, Professor (+302107795553, chrousos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gonadotrophin levels (time frame: up to 9 months of age). The study lists 4 primary outcomes in all. 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 21 Dec 2022.