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 : 1. Assess the efficiency of NO replenishment therapy (i.e. role of NO pathway) as a therapeutic against alterations of minipuberty resulting from preterm birth. 2. 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 Type
OBSERVATIONAL
Enrollment
240
Centre Hospitalier Regional Et Universitaire de Lille
Lille, France
NOT_YET_RECRUITINGURI-NKUA
Athens, Greece
RECRUITINGCentre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
ACTIVE_NOT_RECRUITINGGonadotrophin levels
Serial blood levels of gonadotrophins (FSH and LH)
Time frame: up to 9 months of age
Body fat and fat-free mass
Serial fat and fat-free mass measurements by air displacement plethysmography
Time frame: up to 9 months of age
HOMA-IR
Serial measurements of blood glucose/insulin (HOMA-IR)
Time frame: 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.
Time frame: at 9 months of age
Otoacoustic emissions
Serial otoacoustic emissions as a screening test for hearing ability
Time frame: up to 9 months
Fundoscopy
Ophthalmological follow-up for retina and visual assessment
Time frame: 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.
Time frame: at 3 and 9 months of age
Leptin levels
Serial measurements of serum leptin levels
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Time frame: up to 9 months