Bronchopulmonary Dysplasia
Conditions
Brief summary
It is intended to examine the short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below. 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
1 Days to 10 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Gestational age ≤ 28 weeks + 6 days * Admission within 24 hours after birth. * Clinical presentation and chest X radiograph changes of BPD Clinical presentation: The respiratory symptoms and signs developed within several days or weeks after birth, such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence that requires invasive or non-invasive respiratory supports or oxygen inhalation to maintain blood oxygen saturation. Chest X radiograph changes: The bilateral increased bronchovascular markings or ground-glass opacity and bilateral diffuse increased density, after the possible cause of other diseases such as infection and heart disease have been ruled out. • 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) The Denver Developmental Screening Test primarily assesses the development of infants and young children aged 0-6 years across four domains: Personal-Social, Fine Motor-Adaptive, Language, and Gross Motor. It does not provide a direct "score." Instead, by observing whether a child can complete age-appropriate items, the results are ultimately classified into four categories: Normal, Suspect, Abnormal, and Untestable. |
| 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 | — |
| Tidal Breathing Flow-Volume Curve Parameters | Corrected age/ chronological age of 6 months, 1 year, and 2 years | Measurement of tidal breathing flow-volume curve (TBFV)-derived indices, with primary focus on TPTEF/TE (time to peak tidal expiratory flow to total expiratory time ratio) and VPTEF/VE (volume to peak tidal expiratory flow to total expiratory volume ratio) |
| Composite Clinical Assessment of Pulmonary Function Status | Corrected age/ chronological age of 6 months, 1 year, and 2 years | Categorization of overall pulmonary function status as Normal or Abnormal. As validated normative percentile references for TBFV-derived parameters are unavailable for preterm infants, classification is not based on fixed numerical cutoffs. Instead, the final determination is made through integrative clinical judgment combining: (a) quantitative analysis of TBFV curve parameters (TPTEF/TE and VPTEF/VE), (b) qualitative assessment of TBFV curve morphology (e.g., shape of the flow-volume trajectory, presence of expiratory flow limitation or concavity), and (c) concurrent clinical presentation (e.g., signs of respiratory distress, wheezing, oxygen requirement). The final Normal/Abnormal classification is assigned by the attending clinician based on comprehensive evaluation of all three domains. |
Countries
China
Contacts
CONTACTFu Xuemei
CONTACTLi Dan
PRINCIPAL_INVESTIGATORFu Xuemei
International Peace Maternity and Child Health Hospital
Outcome results
None listed