Evaluation the effect of Intranasal instilation of exosomes extracted from breast milk on the short term outcom of the Intraventricular hemorrhage (IVH Grade 3 or 4 ) in very low birth weight infants

Evaluation the effect of Intranasal instilation of exosomes extracted from breast milk on the short term outcom of the Intraventricular hemorrhage ( IVH Grade 3 or 4 ) in very low birth weight infants

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241122063802N4

Enrollment

Registered

2025-10-10

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraventricular hemorrhage ( IVH Grade 3 or 4 ). Bronchopulmonary dysplasia originating in the perinatal period

Interventions

Intervention 1: Intervention group: Premature infants with grade 3 or 4 IVH receive exosomes extracted from fresh mother's milk (using the ultrafiltration method) intranasally twice daily at 12-hour i

Eligibility

Sex/Gender

All

Age

1 Months to No maximum

Inclusion criteria

Inclusion criteria: Preterm infant with gestational age < 32 weeks and birth weight < 1500 grams Diagnosis of grade 3 or 4 IVH (case group) confirmed by brain ultrasound Access to mother's milk for exosome isolation Written parental consent

Exclusion criteria

Exclusion criteria: Severe congenital brain abnormalities Anatomical nasal disorders that prevent the process of study Uncontrolled systemic infections or severe sepsis Major heart failures except PDA (Patent Ductus Arteriosus) and ASD (Atrial Septal Defect) Serious side effects related to treatment or parental dissatisfaction at any stage Asphyxia or coagulation/vascular or platelet disorders in the newborn

Design outcomes

Primary

Measure	Time frame
Hydrocephalus progression (based on changes in ventricular size on ultrasound). Timepoint: After diagnosis, it will be performed weekly until one month of age and then every two weeks until discharge. Method of measurement: Brain Ultrasound.;Severity of IVH based on the Papile and Volpe scoring system. Timepoint: After diagnosis, it will be performed weekly until one month of age and then every two weeks until discharge. Method of measurement: Brain Ultrasound and CT scan.	—

Measure

Time frame

Hydrocephalus progression (based on changes in ventricular size on ultrasound). Timepoint: After diagnosis, it will be performed weekly until one month of age and then every two weeks until discharge. Method of measurement: Brain Ultrasound.;Severity of IVH based on the Papile and Volpe scoring system. Timepoint: After diagnosis, it will be performed weekly until one month of age and then every two weeks until discharge. Method of measurement: Brain Ultrasound and CT scan.

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Secondary

Measure	Time frame
Growth parameters (weight, length, head circumference). Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Need to supplementary medications such as acetazolamide. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Need for surgical interventions (such as shunt placement, etc.). Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Onset of meningitis. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Length of hospital stay. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Length of hospital stay. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.	—

Measure

Time frame

Growth parameters (weight, length, head circumference). Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Need to supplementary medications such as acetazolamide. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Need for surgical interventions (such as shunt placement, etc.). Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Onset of meningitis. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Length of hospital stay. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.;Length of hospital stay. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Sattarpour

Tabriz University of Medical Sciences

rezasattarpour.tums@gmail.com+98 41 3553 9161

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026