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临床试验/NCT04914806
NCT04914806招募中不适用

Association Between Premature Birth and Its Comorbidities With NO and the HPG Activation at Minipuberty

National and Kapodistrian University of Athens3 个研究点 分布在 3 个国家目标入组 240 人开始时间: 2021年6月1日最近更新:
适应症

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 :

  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.

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Soultana (Tania) Siahanidou

Professor

National and Kapodistrian University of Athens

研究点 (3)

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