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| Name | Class |
|---|---|
| Qilu Children's Hospital of Shandong University | OTHER |
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Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group for children with HIE | Experimental | Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient |
|
| Control group for children with HIE | Active Comparator | Mild hypothermia therapy is given for 72 hours to maintain anal temperature between 33.5°C and 34°C |
|
| Experimental group for children with BPD | Experimental | Intravenous infusion of UCB-MNCs is given within 24 hours of being identified as a high-risk patient |
|
| Control group for children with BPD | Active Comparator | Clinical routine treatment |
|
| Experimental group for children with SBS | Experimental | Intravenous infusion of UCB-MNCs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mononuclear cells | Biological | UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions | Monitor oxygen, heart rate, temperature, rash, infection, etc | Within 12 hours after UCB-MNCs infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications | Children with BPD: The incidence of various complications such as pneumothorax, necrotizing enterocolitis (NEC), intraventricular hemorrhage (grade 3 and above), persistent pulmonary hypertension (PPHN), retinopathy of prematurity (ROP) | a year |
| Imaging test results |
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Inclusion Criteria:
For children with bronchopulmonary dysplasia (BPD): 1) preterm infants with definite gestational age of 25-30 weeks; 2) birth weight 401-1249 g; 3) the risk of BPD was assessed to be greater than 60%. The scoring was based on the BPD high risk scoring system established by the NCHD Neonatal Cooperative Network; 4)parents read the subject's instructions, agreed to the treatment and signed the informed consent.
For children with short bowel syndrome (SBS): 1) postoperative short bowel syndrome caused by neonatal necrotizing enterocolitis and other causes (developmental malformations of the digestive tract: intestinal atresia, anal atresia, intestinal stenosis, etc.); 2) parents read the subject's instructions, agreed to the treatment and signed the informed consent.
Exclusion Criteria:
For children with BPD: 1) with severe anemia, severe intracranial hemorrhage, pulmonary hemorrhage, congenital respiratory malformations (posterior nostril atresia, tracheoesophageal fistula, cleft palate, etc.), complicated congenital heart disease, diaphragmatic hernia, shock, other serious comorbidities or complications (congenital inherited metabolic diseases, endocrine diseases, severe congenital malformations and other diseases that affect lung development); 2) unable or unwilling to provide informed consent or unable to comply with trial requirements.
For children with SBS: unable or unwilling to provide informed consent or unable to comply with trial requirements.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujie Han, MD | Contact | +86 187 5414 6336 | 410358192@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoying Li, MD | Qilu Children's Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Children's Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
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| Control group for children with SBS | Active Comparator | Clinical routine treatment |
|
| Mild hypothermia therapy | Device | Mild hypothermia therapy via hypothermia therapy apparatus |
|
| Breathing support technique | Device | Breathing support via ventilator |
|
| Total parenteral nutrition | Procedure | Liquid nutrition injected directly into the bloodstream |
|
Children with HIE: Brain diffusion tensor imaging (DTI) and 18F-Fluorodeoxyglucose positron emission tomography (18F-FDG-PET/CT) |
| 2 weeks and 6 months after UCB-MNCs infusion |
| Electroencephalography (EEG) results | Children with HIE: The frequency of seizures will be measured via EEG. Seizures appear on EEG as a sudden and transient rise in the lower and/or upper borders of amplitude | 7 days UCB-MNCs infusion |
| Ventilator supporting time | Ventilator supporting time and oxygen demand will be recorded as important indications for clinical prognosis for children with HIE or BPD | 1 month after UCB-MNCs infusion |
| Change of Gross Motor Performance Measure (GMPM) | GMPM is a standardized measurement tool for assessing quality of movement for children with HIE. Higher value means better motor quality | 1, 3, 6 months after UCB-MNCs infusion |
| Change of Gross Motor Function Measure (GMFM) | GMFM is a standardized measurement tool for assessing motor function for children with HIE. It consists of lying & rolling, sitting, crawling & kneeling, standing, etc. Higher value means better gross motor function | 1, 3, 6 months after UCB-MNCs infusion |
| Biomarker of HIE | pNF-H, marker of central nervous system axonal damage | 7 days after UCB-MNCs infusion |
| Biomarker of BPD | AGER, marker of lung epithelial cell damage | 7 days after UCB-MNCs infusion |
| Inflammatory indicators concentrations | Serum IL-6, IL-8, TNF concentrations will be measured via ELISA for children with HIE, BPD or SBS | 7 days after UCB-MNCs infusion |
| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D001997 | Bronchopulmonary Dysplasia |
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010289 | Parenteral Nutrition, Total |
| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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