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IRCT20241122063802N5 IRCT 2025-10-22 Tabriz University of Medical Sciences Investigation of the effect of exosomes extracted from the umbilical cord in the treatment of bronchopulmonary dysplasia in premature infants Investigation of the effect of exosomes extracted from the umbilical cord in the treatment of bronchopulmonary dysplasia in premature infants 2025-11-22 anticipated 30 Recruiting https://irct.ir/trial/86628 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2 Bronchopulmonary dysplasia. Intervention 1: Intervention group: In this group, premature infants with moderate to severe bronchopulmonary dysplasia will be enrolled after obtaining parental consent. This study will use exosomes produced by the Middle East Gene and cell Therapy Company. Collection of human umbilical cord samples will be carried out by obtaining fresh umbilical cords from healthy, term pregnancies, ensuring that informed consent and approval from the ethics committee have been obtained. Processing of these samples will be done within six hours after collection to preserve the integrity of the exosomes. The dose of exosomes is considered to be 10 × 10^8 particles per kilogram of body weight. The administration method is via intratracheal injection through a laryngeal mask over a period of 3 minutes. The number of treatment sessions is twice a week for four weeks. The maximum volume of fluid used will be 5 cc per kilogram of weight to prevent side effects caused by reduced respiratory levels. At the same time, this group will receive standard supportive treatments related to BPD. Intervention 2: Control group: This group will receive routine ward treatment, with the routine treatment protocol similar to the exosome treatment group. At the same time, this group will receive standard supportive treatments related to BPD. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Reza Sattarpour
Al-Zahra Educational and Treatment Center, Baghshamal Intersection, South Army Street
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 3553 9161 rezasattarpour.tums@gmail.com Tabriz University of Medical Sciences scientific Reza Sattarpour
Al-Zahra Educational and Treatment Center, Baghshamal Intersection, South Army Street
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 3553 9161 rezasattarpour.tums@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Premature neonates born with a gestational age ≤32 weeks and 28 weeks or above High-risk neonate for moderate to severe BPD Age of study entry after day 14th of life Neonate is intubated or receiving treatment with FiO2 greater than 30% Obtaining voluntary informed consent 14 days no limit Both Having a major congenital anomaly, including neurological anomalies (such as anencephaly and similar anomalies), liver, kidney, or cardiovascular anomalies (except patent ductus arteriosus, PDA). Having a known genetic syndrome. Having CRP > 30 mg/l or any infection including pneumonia, sepsis, or shock. Having severe (Grade >3) intraventricular hemorrhage (IVH) previously. Being infected with HIV or CMV. Currently participating in any other interventional clinical trial. P27.1 Bronchopulmonary dysplasia originating in the perinatal period Treatment - Drugs Treatment - Other Intervention group: In this group, premature infants with moderate to severe bronchopulmonary dysplasia will be enrolled after obtaining parental consent. This study will use exosomes produced by the Middle East Gene and cell Therapy Company. Collection of human umbilical cord samples will be carried out by obtaining fresh umbilical cords from healthy, term pregnancies, ensuring that informed consent and approval from the ethics committee have been obtained. Processing of these samples will be done within six hours after collection to preserve the integrity of the exosomes. The dose of exosomes is considered to be 10 × 10^8 particles per kilogram of body weight. The administration method is via intratracheal injection through a laryngeal mask over a period of 3 minutes. The number of treatment sessions is twice a week for four weeks. The maximum volume of fluid used will be 5 cc per kilogram of weight to prevent side effects caused by reduced respiratory levels. At the same time, this group will receive standard supportive treatments related to BPD. Control group: This group will receive routine ward treatment, with the routine treatment protocol similar to the exosome treatment group. At the same time, this group will receive standard supportive treatments related to BPD. Pulmonary function and severity of BPD at 3 months. Timepoint: Beginning and end of the study. Method of measurement: NIH BPD severity scale. Mechanical ventilation cases and complications related to BPD. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study. Duration of oxygen requirement. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study. Duration of hospitalization. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study. Mortality. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire filled out during the study. Tabriz University of Medical Sciences Approved 2025-10-06 Ethics committee of Tabriz University of Medical Sciences Central Building of Tabriz University of Medical Sciences, Azadi Ave., Golgasht St., Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)