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| Name | Class |
|---|---|
| URI-NKUA | UNKNOWN |
| University Hospital, Lille | OTHER |
| Centre Hospitalier Universitaire Vaudois | OTHER |
| European Commission |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Gonadotrophin levels | Serial blood levels of gonadotrophins (FSH and LH) | up to 9 months of age |
| Body fat and fat-free mass | Serial fat and fat-free mass measurements by air displacement plethysmography | up to 9 months of age |
| HOMA-IR | Serial measurements of blood glucose/insulin (HOMA-IR) | 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. | at 9 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Otoacoustic emissions | Serial otoacoustic emissions as a screening test for hearing ability | up to 9 months |
| Fundoscopy | Ophthalmological follow-up for retina and visual assessment |
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Inclusion Criteria:
Exclusion Criteria:
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Preterm and full-term infants admitted to the Neonatal Unit due to respiratory distress.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George P. Chrousos, Professor | Contact | +302107795553 | chrousos@gmail.com | |
| Soultana (Tania) Siahanidou, Professor | Contact | +30213 2013 517 | siahan@med.uoa.gr |
| Name | Affiliation | Role |
|---|---|---|
| George P. Chrousos, Professor | URI-NKUA, Athens, Greece, 11527 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Regional Et Universitaire de Lille | Not yet recruiting | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
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Blood samples for hormones and metabolic parameters; genetic and epigenetic screening for NO pathway.
| 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. | at 3 and 9 months of age |
| Leptin levels | Serial measurements of serum leptin levels | up to 9 months |
| URI-NKUA | Recruiting | Athens | 11527 | Greece |
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| Centre Hospitalier Universitaire Vaudois | Active, not recruiting | Lausanne | 1005 | Switzerland |
| D000091642 | Urogenital Diseases |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |