Infantile NO Replenishment as a New Therapeutic Possibility

Prematurity Clinical Trial

— miniNO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914806
• Other study ID #: miniNO
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2022
• Source: National and Kapodistrian University of Athens
• Contact: George P. Chrousos, Professor
• Phone: +302107795553
• Email: chrousos[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Prematurity
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
France	Centre Hospitalier Regional Et Universitaire de Lille	Lille
Greece	URI-NKUA	Athens
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (5)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	Centre Hospitalier Universitaire Vaudois, European Commission, University Hospital, Lille, URI-NKUA

Countries where clinical trial is conducted

France,  Greece,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gonadotrophin levels	Serial blood levels of gonadotrophins (FSH and LH)	up to 9 months of age
Primary	Body fat and fat-free mass	Serial fat and fat-free mass measurements by air displacement plethysmography	up to 9 months of age
Primary	HOMA-IR	Serial measurements of blood glucose/insulin (HOMA-IR)	up to 9 months
Primary	Bayleys scale score	The Bayley Scales of Infant and Toddler Development will be used to assess neurodevelopment. Values <85 indicate developmental delay.	at 9 months of age
Secondary	Otoacoustic emissions	Serial otoacoustic emissions as a screening test for hearing ability	up to 9 months
Secondary	Fundoscopy	Ophthalmological follow-up for retina and visual assessment	up to 9 months
Secondary	gusto-facial reflex	Assessment of olfaction will be performed using a citrus, vanilla or neutral odor, delivered on a cotton swab. The facial expressions in reaction to the different smells (the gusto-facial reflex) will be monitored while at rest (baseline), and in response to stimuli.	at 3 and 9 months of age
Secondary	Leptin levels	Serial measurements of serum leptin levels	up to 9 months