Bronchopulmonary dysplasia. Bronchopulmonary dysplasia originating in the perinatal period
Conditions
Interventions
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
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
14 Days to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Sattarpour
Tabriz University of Medical Sciences
Outcome results
None listed