Association Between Premature Birth and Its Comorbidities With NO and the HPG Activation at Minipuberty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Gonadotrophin levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 3 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm (GA<37 weeks) or full-term (≥37 weeks of gestation) infants
- •Requiring respiratory support
- •Admitted to Neonatal Care Unit
排除标准
- •Severe congenital anomalies
- •Suspected major chromosomal anomalies
- •Infants judged by the physician as nonviable
结局指标
主要结局
Gonadotrophin levels
时间窗: up to 9 months of age
Serial blood levels of gonadotrophins (FSH and LH)
Bayleys scale score
时间窗: 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
时间窗: up to 9 months of age
Serial fat and fat-free mass measurements by air displacement plethysmography
HOMA-IR
时间窗: up to 9 months
Serial measurements of blood glucose/insulin (HOMA-IR)
次要结局
- 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)
研究者
Soultana (Tania) Siahanidou
Professor
National and Kapodistrian University of Athens
