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Infantile NO Replenishment as a New Therapeutic Possibility

NCT ID: NCT04914806

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prematurity Respiratory Distress Syndrome, Newborn

Keywords

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preterm birth neurodevelopment cardiometabolic minipuberty

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Infants treated with iNO (from birth to 1-3 weeks of life) or sequential treatment with iNO and sildenafil (for 1 to 3 months).

No interventions assigned to this group

Controls

Infants matched to cases (gestational/postnatal age, gender, disease state) and no iNO treatment.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URI-NKUA

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role collaborator

European Commission

OTHER

Sponsor Role collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Soultana (Tania) Siahanidou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George P. Chrousos, Professor

Role: STUDY_CHAIR

URI-NKUA, Athens, Greece, 11527

Locations

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Centre Hospitalier Regional Et Universitaire de Lille

Lille, , France

Site Status NOT_YET_RECRUITING

URI-NKUA

Athens, , Greece

Site Status RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Countries

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France Greece Switzerland

Central Contacts

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George P. Chrousos, Professor

Role: CONTACT

Phone: +302107795553

Email: [email protected]

Soultana (Tania) Siahanidou, Professor

Role: CONTACT

Phone: +30213 2013 517

Email: [email protected]

Facility Contacts

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Laurent Storme, Professor

Role: primary

George Chrousos, Professor

Role: primary

Tania Siahanidou, Professor

Role: backup

Other Identifiers

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miniNO

Identifier Type: -

Identifier Source: org_study_id