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Table 2 Timeline and items of evaluation during the trial

From: Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial)

ItemsStudy period
Screening phaseTreatment phaseFollow-up phase
− 2 weeksBaseline24 hours3 days7 days1 month3 months6 months12 months24 months
TherapyhUC-MSCs        
Traditional treatment     
Informed consent         
Inclusion and exclusion criteria        
Demographic information         
Personal history/past history/family history    
Height/weight/head circumference  
Vital signsa/physical examination  
Hematologyb/blood biochemistryc/urinalysise       
Infectious disease-related examinationd       
Blood oxygen saturation/blood gas analysis   
Chromosome examination         
Brain MRI examination      
EKG       
Echocardiogram         
Ventilator parameters/oxygen therapy 
Adverse events evaluation 
Chest high resolution CT      
Pulmonary function test      
Mortality/complications of prematurityf     
  1. Legend: CK-MB creatine kinase-MB, CT, computed tomography EKG electrocardiogram, hUS-MSCs human umbilical-cord mesenchymal stem cells
  2. aThe indicators of vital signs include temperature, blood pressure, heart rate, respiratory rate, transcutaneous oxygen saturation
  3. bThe condition of hematology of participants will be estimated by hematological tests which contains white blood cell count, platelet count, red blood cell count, hemoglobin, the percentage of lymphocytes, the percentage of neutrophil and C-reactive protein (CRP)
  4. cThe items of blood biochemistry include liver function, renal function, cardiac markers, the indicators of immunity, and the detailed items of each test are listed as follow. Liver function tests: albumin, bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, prothrombin time, activated partial thromboplastin time. Renal function tests: creatinine, blood urea nitrogen, creatinine clearance, glomerular filtration rate. Cardiac markers: hypersensitive troponin I, CK-MB mass, myoglobin
  5. dInfectious disease-related examination include markers of hepatitis/syphilis/HIV/tuberculosis
  6. eThe content of urinalysis includes pH, protein, specific gravity, glucose and ketone bodies, white blood cells, occult blood or red blood cells, nitrite, color, and turbidity
  7. fComplications of prematurity include growth retardation or retardation, hearing abnormalities, retinopathy, pulmonary hypertension, left ventricular hypertrophy