neonate
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newborns requiring PICC catheterization; 2. PICC retention time > 2 weeks; 3. Weight gain during PICC retention > 10%; 4. The bleeding and clotting time is normal; 5. No serious contraction or collapse of peripheral blood vessels; 6. Parents are informed and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of another primary malignancy within 2 years before screening, with the exception of cured cutaneous squamous cell carcinoma, skin basal cell carcinoma, non-muscle-invasive bladder cancer, localized low-risk prostate cancer [stage 103 copies/mL) who are willing to continue antiviral therapy according to local standard treatment and whose liver function meets the inclusion criteria can be enrolled; Patients with a history of HCV infection but has negative PCR results for HCV RNA can be enrolled; (5) Patients received systemic corticosteroids (intravenous or broad-spectrum oral antibiotics for more than 1 week) within 28 days prior to the first administration of investigational product; 4. Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for patients with clinically stable autoimmune thyroid disease; 5. Patients who with an allo-transplant of any kind (including those with a xenograft heart valve); 6. Any significant ophthalmologic abnormality, including but not limited to the following: (1) Grade 2 or greater severity syndrome of dry eye; (2) Iritis. 7. Patients who have a history of definite neurological disorders that affected brain function activity, including epilepsy or dementia; 8. Patients with thrombotic or embolic events, such as cerebrovascular accident, uncontrolled deep vein thrombosis, pulmonary embolism, etc., within 6 months prior to the first dose of investigational product; Patients who is currently receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or similar drugs, or long-term nonsteroidal anti-inflammatory drug (NSAID) therapy; Prophylactic anticoagulation by open intravenous delivery systems is permitted, as long as the coagulation conditions required for enrollment are met within 7 days prior to initiation of investigational product; 9. Patients with clinically significant bleeding, or a clear bleeding tendency, such as gastroesophageal varices, gastrointestinal bleeding, hemorrhagic gastric ulcer, etc. within 3 months before the start of administration; patient with clinically significa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Countries
China
Contacts
Children's Hospital of Chongqing Medical University