Health TrialsbyHealthPanel

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

ConditionsPremature BirthExtreme PrematurityPreterm Intraventricular HemorrhageHypoxia-Ischemia, CerebralNeurodevelopmental Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorFederal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

About this trial

To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exosomes derived from mesenchymal stromal cells (MSCs)

    Other intervention

    Exosomes derived from mesenchymal stromal cells (MSCs) will be administered intranasal in ELBW infants

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Intranasal exosomes administrationExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Occurrence and rate of dose limiting toxicity

Dose limiting toxicity consists of the following events: Death occurring within 24 hours after intranasal administration of EVs; Hypersensitivity / anaphylactic to EVs defined as any severe systemic inflammatory response syndrome with negative blood culture not consistent with the overall clinical course of the infant occurring within 72 hours after intranasal administration of EVs; Any other serious adverse event not expected in this patient population for which there is no alternative explanation but the administration of EVs, occurring within 1 week of injection.

Time frame
Up to 1 week following after intranasal administration of EVs

Secondary outcomes

1

Rate of death

Rate of death until discharge or 40 weeks corrected gestational age, whichever comes first

Time frame
From enrollment until discharge or 40 weeks corrected gestational age (whichever occurs first)
2

Occurrence of Other Severe Complications of Prematurity

* Blood culture-proven sepsis * Patent ductus arteriosus (treated medically or surgically) * Necrotizing enterocolitis * Isolated intestinal perforation * Retinopathy of prematurity requiring treatment * Severe intraventricular hemorrhage (≥ grade 3) * Cystic periventricular leukomalacia * Incidence and Severity of BPD, Measured as mild, moderate, or severe

Time frame
From enrollment until discharge or 40 weeks corrected gestational age (whichever occurs first)
3

Need for Ventilatory Support

* Time to extubation * Duration of mechanical ventilation * Duration of non-invasive positive pressure respiratory support * Duration of supplemental oxygen

Time frame
From enrollment until discharge, 40 weeks corrected gestational age, or death (whichever occurs first)
4

Changes in Hemodynamics

Targeted neonatal echocardiography to assess

Time frame
Time Frame: At enrollment, 48 hours following intranasal administration of EVs, 28 days of life, and 36 weeks corrected gestational age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: