Bronchopulmonary Dysplasia
Conditions
Brief summary
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.
Interventions
DRUGintravenous immunoglobulin
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.
Sponsors
International Peace Maternity and Child Health Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Gestational age between 25 weeks and 29 weeks + 6 days * Admission within 24 hours after birth. * Clinical symptoms and chest X-ray results show a highly suspicion of BPD （Clinical symptoms and chest X-ray changes of BPD）.Clinical symptoms develop in several days or weeks after birth, including respiratory symptoms and signs such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence (increased oxygen concentration and assisted ventilation) .One of the following signs present in chest X-ray: lung texture thickening or ground glass opacity in early stage, diffuse lung texture blurred, lung hyperinflation, shadow of linear density increased, and shadow of triangular density increased under the pleura. * A normal full-term newborn without a history of severe lung diseases, birth asphyxia, hypoxic-ischemic encephalopathy or other conditions that may affect the development of the respiratory, nervous and other systems.
Exclusion criteria
* Major congenital anomalies(e.g., congenital heart disease, congenital craniocerebral deformity, congenital structural abnormality of respiratory system, congenital hereditary metabolic disease) * Chromosomal defects (e.g., trisomy 13, 18, 21) * Severe intracranial hemorrhage * Multiple organ failure * With severe lung infections * Other circumstances that the investigator determines are not suitable for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA | 36 weeks of postmenstrual age | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of respiratory support | until first discharge home or 36 weeks PMA | Defined as cumulative days on assisted ventilation, support with oxygen, or both |
| Preterm birth complications | until first discharge home or 36 weeks PMA | Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al. |
| Neurodevelopmental assessment | Corrected age/ chronological age of 6 months, 1 year, and 2 years. | Neurodevelopmental testing (e.g., Denver Developmental Screening Test) |
| Pulmonary function testing | Corrected age/ chronological age of 6 months, 1 year, and 2 years | 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. |
| Vision screening | Corrected age/ chronological age of 6 months, 1 year, and 2 years | Vision screening with Spot Vision Screener |
| Bone density measurement | Corrected age/ chronological age of 6 months, 1 year, and 2 years | — |
| Blood routine tests | Corrected age/ chronological age of 6 months, 1 year, and 2 years | Including white blood cell count, differential white blood cell count (such as neutrophils, lymphocytes, etc.), red blood cell count, hemoglobin concentration, platelet count, etc |
| Rehabilitation evaluation | Corrected age/ chronological age of 6 months and 1 year | e.g., Alberta Infant Motor Scale Assessment Report, 0-58 (min- max value), higher scores mean a better outcome. |
| 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 | — |
Countries
China
Contacts
CONTACTFu Xuemei
CONTACTLi Dan
PRINCIPAL_INVESTIGATORFu Xuemei
International Peace Maternity and Child Health Hospital
Outcome results
None listed