Bronchopulmonary Dysplasia
Conditions
Keywords
Bronchopulmonary Dysplasia, Mesenchymal stem cell
Brief summary
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
Detailed description
Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking. Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.
Interventions
The Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10\^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube
DRUGplacebo
saline
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 3 Weeks
Healthy volunteers
No
Inclusion criteria
* Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age * Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age
Exclusion criteria
* Patients with severe congenital diseases * Patients with IVH more than 3 grade * Patients with severe sepsis * Patients with active pulmonary hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen requirement 3 days after transplantation | 3 days | Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of ventilator dependence | up to 36 weeks PMA | The duration from transplantation to weaning from ventilator |
| Incidence of severe BPD | up to 36 weeks PMA | percentage of participants with severe BPD ,diagnosed at 36 weeks PMA |
| Survival rate | up to 36 weeks PMA | Percentage of participants who survived up to 36 weeks PMA |
| Temperature | 3 days | Temporal profiles of temperature |
| Heart rate | 3 days | Temporal profiles of heart rate |
| Oxygen requirement 7 days after transplantation | 7 days | Temporal profiles of the fraction of inspiration oxygen 7 days after transplantation, the tolerable required oxygen ，which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in % |
| Duration of CPAP treatment | up to 36 weeks PMA | Duration of CPAP treatment |
| Percentage of participants treated with steroids for weaning from ventilator | up to 36 weeks PMA | Percentage of participants treated with steroids for weaning from ventilator |
| Growth velocity (Z-score) | up to 36 weeks PMA | percentile for body weight, height, and head circumference |
| bronohoalveolar lavage (BAL) cytokine level | 7 days | BAL were collected 7 days after transplantation for cytokine (IL-6，IL-8，TNF-α，TGF-β,VEGF,HGF) level examination, measured in pg/ml |
| The severity of BPD in X-ray patterns | 7 days | A chest X-ray was performed in participants before and after transplantation. The severity of BPD (mild，moderate，severe) was assessed by a single radiographic doctor who is blind about randomization |
| Respiratory rate | 3 days | Temporal profiles of respiratory rate |
Countries
China
Outcome results
None listed