NCT05986994

Identification of a Pool of miRNA to Improve Early Management of Perinatal Asphyxia and Hypoxic Ischemic Encephalopathy

Status unknown Last updated 14 August 2023

What this trial tests

trial testing Metabolic acidosis in Hypoxic-Ischemic Encephalopathy in 45 participants. Status unknown.

Timeline

18 July 2023

Primary endpoint
18 July 2024

18 July 2024

Quick facts

Lead sponsor	Ospedale Buon Consiglio Fatebenefratelli
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	45
Start date	18 July 2023
Primary completion	18 July 2024
Estimated completion	18 July 2024
Sites	2 locations across Italy

Drugs / interventions tested

• Metabolic acidosis
• microRNA
• Hypothermia

Conditions studied

• Hypoxic-Ischemic Encephalopathy — all drugs for Hypoxic-Ischemic Encephalopathy →
• Asphyxia Perinatal — all drugs for Asphyxia Perinatal →

Sponsor

Ospedale Buon Consiglio Fatebenefratelli

Who can join

Adults 35 Weeks to 42 Weeks, any sex, with Hypoxic-Ischemic Encephalopathy or Asphyxia Perinatal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hypoxic-ischemic encephalopathy is the most common cause of neurological damage in the neonatal period. It has an incidence of about 1.5-2.5% of livebirths in developed countries. It is associated with a high rate of mortality and morbidity. Major neurological outcomes such as cerebral palsy, mental retardation, learning disabilities, epilepsy occur in approximately 25% of survivors. The diagnostic and prognostic tools currently available for enrollment have limitations and additional reliable biomarkers are needed for all phases of clinical management. Sarnat staging has taken on a role in identifying those infants who may benefit from treatment of hypothermia, resulting in the need for neurological evaluation and staging within 6 hours of life. Therapeutic hypothermia is still the best therapeutic treatment.

A new tool in neuroscience research is represented by micro-ribonucleic acid (microRNA) profiling. The presence of microRNAs in blood, urine and saliva and the ability to measure their levels non-invasively has opened new doors in the search for peripheral biomarkers for the diagnosis and prognosis of neurodegenerative diseases and also as possible pharmacological targets.

The aim of the present study is to analyze a specific cluster of miRNAs selected from data obtained by macroarray (NGS Pannel) on the entire microRNAome in healthy newborns with normal cord arterial pH value (7.26-7.35) as control cases and in newborns with fetal metabolic acidosis with a pH threshold value lower than 7.12 of the blood gas analysis from cord arterial blood. This latter group will be further stratified into two groups, neonates who will practice therapeutic hypothermia according to current guidelines and a further group who will not practice therapeutic hypothermia. This study will make a further international contribution in evaluating and identifying the potential of microRNAs as diagnostic and prognostic biomarkers in perinatal asphyxia and hypoxic ischemic encephalopathy. Furthermore, the study aims to identify specific microRNA sequences as new possible markers to be used as an additional parameter for the enrollment of therapeutic hypothermia, especially in cases of mild hypoxic-ischemic encephalopathy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. miR223, miR30e, and miR30a show associations with perinatal metabolic acidosis in neonates with hypoxic-ischemic encephalopathy.
   Patil RM, Miele M, Giordano M, Fattorusso V, et al · · 2026 · PMID 41706310 · DOI 10.1186/s40348-026-00220-9