Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It is intended to examine the efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms. Participants will received continuous infusion IVIG 1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable if necessary.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous immunoglobulin | Drug | 1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable if necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA | According to the diagnosis criteria published by National Institute of Child Health and Human Development in 2018, a premature infant (<32 weeks'gestational age) with BPD has persistent parenchymal lung disease, radiographic confirmation of parenchymal lung disease, and at 36 weeks PMA requires 1 of the following FiO2 ranges/oxygen levels/O2 concentrations for ≥3 consecutive days to maintain arterial oxygen saturation in the 90%-95% range. (We have rephrased the title and description to better recapitulate the original intent of the IRB-approved protocol) | 36 weeks of postmenstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| duration of respiratory support | Defined as cumulative days on assisted ventilation, support with oxygen, or both | until first discharge home or 36 weeks PMA |
| Preterm birth complications | Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fu Xuemei | Contact | +86 18017313931 | fxmzj2004@163.com | |
| Li Dan | Contact | +86 18814100771 | lidan910327@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Fu Xuemei | International Peace Maternity and Child Health Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Peace Maternity and Child Health Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
Not provided
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| until first discharge home or 36 weeks PMA |
| Neurodevelopmental assessment | Neurodevelopmental testing (e.g., Denver Developmental Screening Test) | Corrected age/ chronological age of 6 months, 1 year, and 2 years. |
| Pulmonary function testing | Normal/Abnormal. Pulmonary function testing includes the following parameters: Breathing Frequency (BF), Inspiratory Time (TI)/ Expiratory Time Ratio (TE), Tidal Volume (VT), Time to Peak Tidal Expiratory Flow (TPTEF), Volume to Peak Tidal Expiratory Flow (VPTEF), etc. The determination of abnormal lung function in infants is primarily relies on the analysis of TPTEF/TE and VPTEF/VE ratios, the shape of the TBFV (Tidal Breathing Flow-Volume) loop, and the integration of clinical presentation. | Corrected age/ chronological age of 6 months, 1 year, and 2 years |
| Vision screening | Vision screening with Spot Vision Screener | Corrected age/ chronological age of 6 months, 1 year, and 2 years |
| Bone density measurement | Corrected age/ chronological age of 6 months, 1 year, and 2 years |
| Blood routine tests | Including white blood cell count, differential white blood cell count (such as neutrophils, lymphocytes, etc.), red blood cell count, hemoglobin concentration, platelet count, etc | Corrected age/ chronological age of 6 months, 1 year, and 2 years |
| Rehabilitation evaluation | e.g., Alberta Infant Motor Scale Assessment Report, 0-58 (min- max value), higher scores mean a better outcome. | Corrected age/ chronological age of 6 months and 1 year |
| Weight | Corrected age/ chronological age of 6 months, 1 year, and 2 years |
| Length | Corrected age/ chronological age of 6 months, 1 year, and 2 years |
| Head circumference | Corrected age/ chronological age of 6 months, 1 year, and 2 years |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |