Prematurity, Respiratory Distress Syndrome, Newborn
Conditions
Keywords
preterm birth, neurodevelopment, cardiometabolic, minipuberty
Brief 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 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 : 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.
Interventions
None listed
Sponsors
URI-NKUA
University Hospital, Lille
Centre Hospitalier Universitaire Vaudois
European Commission
National and Kapodistrian University of Athens
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Weeks
Healthy volunteers
No
Inclusion criteria
* Preterm (GA\<37 weeks) or full-term (≥37 weeks of gestation) infants * Requiring respiratory support * Admitted to Neonatal Care Unit
Exclusion criteria
* Severe congenital anomalies * Suspected major chromosomal anomalies * Infants judged by the physician as nonviable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bayleys scale score | at 9 months of age | The Bayley Scales of Infant and Toddler Development will be used to assess neurodevelopment. Values \<85 indicate developmental delay. |
| Gonadotrophin levels | up to 9 months of age | Serial blood levels of gonadotrophins (FSH and LH) |
| Body fat and fat-free mass | up to 9 months of age | Serial fat and fat-free mass measurements by air displacement plethysmography |
| HOMA-IR | up to 9 months | Serial measurements of blood glucose/insulin (HOMA-IR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Otoacoustic emissions | up to 9 months | Serial otoacoustic emissions as a screening test for hearing ability |
| Fundoscopy | up to 9 months | Ophthalmological follow-up for retina and visual assessment |
| gusto-facial reflex | at 3 and 9 months of age | 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. |
| Leptin levels | up to 9 months | Serial measurements of serum leptin levels |
Countries
France, Greece, Switzerland
Contacts
Primary ContactGeorge P. Chrousos, Professor
Backup ContactSoultana (Tania) Siahanidou, Professor
Outcome results
None listed