Investigating the effects of inhaled Nitric Oxide on preterm infants
Association Between Premature Birth and Its Comorbidities With NO and the HPG Activation at Minipuberty
This study is testing if inhaled Nitric Oxide can help improve the health of preterm infants and reduce future health problems related to their early birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 1 Day to 3 Weeks |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 3 sites (Lille and 2 other locations) |
| Trial ID | NCT04914806 on ClinicalTrials.gov |
What this trial studies
This observational study examines the impact of inhaled Nitric Oxide (iNO) treatment on full-term and preterm infants, particularly focusing on the relationship between premature birth and subsequent health issues such as neurodevelopmental and metabolic disorders. The study aims to assess how iNO therapy may influence the maturation of the hypothalamic-pituitary-gonadal (HPG) axis during a critical period known as minipuberty. By evaluating these associations, the research seeks to identify potential therapeutic benefits of NO replenishment in mitigating the long-term comorbidities associated with prematurity.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at less than 37 weeks of gestation or full-term infants requiring respiratory support.
Not a fit: Patients with severe congenital anomalies or major chromosomal anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved therapeutic strategies for preterm infants, potentially reducing the risk of long-term health complications.
How similar studies have performed: While the approach of using iNO in preterm infants is established, the specific focus on its effects on minipuberty and long-term comorbidities is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille and 2 other locations
- Centre Hospitalier Regional Et Universitaire de Lille — Lille, France (Not_yet_recruiting)
- Uri-Nkua — Athens, Greece (Recruiting)
- Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland (Active_not_recruiting)
Study contacts
- Study coordinator: George P. Chrousos, Professor
- Email: chrousos@gmail.com
- Phone: +302107795553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.