Investigation of the effect of exosomes extracted from the umbilical cord in the treatment of bronchopulmonary dysplasia in premature infants

Comparison of pulmonary function and severity of BPD at 3 months in both study groups.

This is a randomized, double-blind, parallel-group, controlled phase 2 clinical trial on 30 patients. The R software was used for randomization.

In this study, two groups of 15 premature infants with moderate to severe bronchopulmonary dysplasia will be randomly selected who were hospitalized between the years 2025 to 2026 at Al-Zahra Hospital in Tabriz - neonatal intensive care unit. Researchers, evaluators, and patients will be blinded to the intervention.

Inclusion criteria: Premature infants born with a gestational age less than or equal to 32 weeks and 28 weeks or more, high-risk infants for moderate to severe bronchopulmonary dysplasia, and infants who are intubated or receiving treatment with an oxygen concentration fraction higher than 30%. Exclusion criteria: Major congenital anomalies, including neurological anomalies (such as anencephaly and similar anomalies), liver, kidney, cardiovascular anomalies (except for patent ductus arteriosus, PDA), any infections including pneumonia, sepsis, or shock, severe intraventricular hemorrhage.

In the case group, premature infants with moderate to severe bronchopulmonary dysplasia will be admitted and will receive exosomes extracted from the umbilical cord through a laryngeal mask. Infants in the control group will receive routine ward treatments and conventional respiratory care.

Pulmonary function and severity of BPD at 3 months; Mechanical ventilation cases and complications related to BPD; Duration of oxygen requirement; Duration of hospitalization; Mortality

The selection of participants will be done randomly in a 1:1 ratio to receive either exosome treatment or standard treatment alone, using computer-generated random blocks with R software.

In this study, double blinding is performed by ensuring that neither the infants' parents nor the medical staff and outcome assessors are aware of the type of treatment administered (exosome or standard treatment), thereby preventing bias.

Due to the use of hospital data and the confidentiality policies of the university and hospital, public release of the data will be avoided. However, researchers may contact the responsible person to request access to the data.

Due to the use of hospital data and the confidentiality policies of the university and hospital, public release of the data will be avoided. However, researchers may contact the responsible person to request access to the data.

Due to the use of hospital data and the confidentiality policies of the university and hospital, public release of the data will be avoided. However, researchers may contact the responsible person to request access to the data.

Due to the use of hospital data and the confidentiality policies of the university and hospital, public release of the data will be avoided. However, researchers may contact the responsible person to request access to the data.

Hospitals and affiliated institutions have policies to maintain confidentiality and secure data access, often implementing role-based access control (RBAC) to limit who can view or use patient information based on their role and necessity.

For research purposes, contact is typically made with the hospital’s research office or ethics committee to obtain necessary approvals and ensure compliance with confidentiality agreements.

Submission of a Written Request: The requester must submit a formal written application specifying the data or documents needed and the intended use. Patient Consent: For access to identifiable medical records, written consent from the patient (or legal guardian) is required unless exceptions apply (e.g., emergencies, legal orders). Review and Approval: The hospital’s Medical Records Department and/or Ethics Committee review the request to ensure compliance with privacy policies and legal regulations. Data Preparation: Upon approval, the requested data are prepared, which may include de-identification or anonymization if for research purposes. Confidentiality Agreement: The requester may be required to sign a confidentiality agreement or data use agreement to protect patient privacy. Data Delivery: The data or documents are provided securely, often with a certification (e.g., “Certified True Copy”) if official copies are requested.