Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia, Short Bowel Syndrome
Conditions
Brief summary
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.
Interventions
BIOLOGICALMononuclear cells
UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation
DEVICEMild hypothermia therapy
Mild hypothermia therapy via hypothermia therapy apparatus
DEVICEBreathing support technique
Breathing support via ventilator
PROCEDURETotal parenteral nutrition
Liquid nutrition injected directly into the bloodstream
Sponsors
Qilu Children's Hospital of Shandong University
Shandong Qilu Stem Cells Engineering Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* For children with hypoxic-ischemic encephalopathy (HIE): meet the diagnostic criteria for HIE. 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 HIE: unable or unwilling to provide informed consent or unable to comply with trial requirements. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions | Within 12 hours after UCB-MNCs infusion | Monitor oxygen, heart rate, temperature, rash, infection, etc |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Imaging test results | 2 weeks and 6 months after UCB-MNCs infusion | Children with HIE: Brain diffusion tensor imaging (DTI) and 18F-Fluorodeoxyglucose positron emission tomography (18F-FDG-PET/CT) |
| Electroencephalography (EEG) results | 7 days UCB-MNCs infusion | 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 |
| Ventilator supporting time | 1 month after UCB-MNCs infusion | Ventilator supporting time and oxygen demand will be recorded as important indications for clinical prognosis for children with HIE or BPD |
| Change of Gross Motor Performance Measure (GMPM) | 1, 3, 6 months after UCB-MNCs infusion | GMPM is a standardized measurement tool for assessing quality of movement for children with HIE. Higher value means better motor quality |
| Incidence of complications | a year | 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) |
| Biomarker of HIE | 7 days after UCB-MNCs infusion | pNF-H, marker of central nervous system axonal damage |
| Biomarker of BPD | 7 days after UCB-MNCs infusion | AGER, marker of lung epithelial cell damage |
| Inflammatory indicators concentrations | 7 days after UCB-MNCs infusion | Serum IL-6, IL-8, TNF concentrations will be measured via ELISA for children with HIE, BPD or SBS |
| Change of Gross Motor Function Measure (GMFM) | 1, 3, 6 months after UCB-MNCs infusion | 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 |
Countries
China
Contacts
Primary ContactYujie Han, MD
Outcome results
None listed