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Infantile NO Replenishment as a New Therapeutic Possibility — miniNO  

Prematurity Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04914806
Study type Observational
Source National and Kapodistrian University of Athens
Contact George P. Chrousos, Professor
Phone +302107795553
Email chrousos@gmail.com
Status Recruiting
Phase
Start date June 1, 2021
Completion date December 31, 2025
View Details
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