Association Between Premature Birth and Its Comorbidities With NO and the HPG Activation at Minipuberty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- National and Kapodistrian University of Athens
- Enrollment
- 240
- Locations
- 3
- Primary Endpoint
- Gonadotrophin levels
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Soultana (Tania) Siahanidou
Professor
National and Kapodistrian University of Athens
Eligibility Criteria
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
Outcomes
Primary Outcomes
Gonadotrophin levels
Time Frame: up to 9 months of age
Serial blood levels of gonadotrophins (FSH and LH)
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.
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)
Secondary Outcomes
- Otoacoustic emissions(up to 9 months)
- Fundoscopy(up to 9 months)
- gusto-facial reflex(at 3 and 9 months of age)
- Leptin levels(up to 9 months)