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

Table 2 Timeline and items of evaluation during the trial

Items		Study period
		Screening phase	Treatment phase				Follow-up phase
		− 2 weeks	Baseline	24 hours	3 days	7 days	1 month	3 months	6 months	12 months	24 months
Therapy	hUC-MSCs	√	√
Therapy	Traditional treatment	√	√	√	√	√
Informed consent		√
Inclusion and exclusion criteria		√	√
Demographic information		√
Personal history/past history/family history		√					√	√	√	√	√
Height/weight/head circumference		√	√			√	√	√	√	√	√
Vital signs^a/physical examination		√	√	√	√	√			√	√	√
Hematology^b/blood biochemistry^c/urinalysis^e		√	√	√
Infectious disease-related examination^d		√	√	√
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 prematurity^f							√	√	√	√	√

Legend: CK-MB creatine kinase-MB, CT, computed tomography EKG electrocardiogram, hUS-MSCs human umbilical-cord mesenchymal stem cells
^aThe indicators of vital signs include temperature, blood pressure, heart rate, respiratory rate, transcutaneous oxygen saturation
^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)
^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
^dInfectious disease-related examination include markers of hepatitis/syphilis/HIV/tuberculosis
^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
^fComplications of prematurity include growth retardation or retardation, hearing abnormalities, retinopathy, pulmonary hypertension, left ventricular hypertrophy

ISSN: 1745-6215