The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants

Launched by FEDERAL STATE BUDGET INSTITUTION RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGY AND PERINATOLOGY MINISTRY OF HEALTHCARE · Aug 3, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment to help protect the brains of extremely low birth weight infants, who are born very early at a gestational age of 25 to 27 weeks. The researchers are testing a substance called exosomes, which are tiny particles that come from special cells and may help with brain development. The goal is to see if giving these exosomes through the nose can improve long-term brain health and development in these vulnerable infants.

To participate in this study, infants must be born between 25 and 27 weeks of pregnancy and meet certain health criteria. Unfortunately, babies with serious birth defects or who are not expected to survive will not be eligible. If selected for the study, families will be involved in regular check-ups to monitor the baby's progress and development over time. It's important to note that this trial is not yet recruiting participants, so families will need to wait for more information if they are interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Premature newborns of gestational age (GA) 25/0-27/6 weeks,
• Exclusion Criteria:
• • Missing written parental consent
• • Damages to the nasal mucosa
• • Maxillofacial defects
• • Major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period)
• • Infants who died before 48 hours, infants in whom the clinical decision to withhold intensive care was made, infants who were not considered viable
• • Infants with edematous hemolytic disease of newborns, non-immune fetal dropsy,
• • Multifetal Gestations
• • Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study