Bronchopulmonary DysplasiaPhase 2NCT06925360
IVIG Trial for the Treatment of Bronchopulmonary Dysplasia
A Phase 2 study testing intravenous immunoglobulin in people with Bronchopulmonary Dysplasia, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- intravenous immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2025to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality
Peng aiping, +86 021 64070434 ext. 50407, gfykyll@163.com
About this study
Official title: The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia
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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- intravenous immunoglobulin
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous immunoglobulinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| IVIG | Experimental | Not described Receives: Drug: intravenous immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 36 weeks of postmenstrual age
Secondary outcomes (11)
duration of respiratory support
Defined as cumulative days on assisted ventilation, support with oxygen, or both
Measured: 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.
Measured: until first discharge home or 36 weeks PMA
Neurodevelopmental assessment
Neurodevelopmental testing (e.g., Denver Developmental Screening Test)
Measured: 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.
Measured: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Vision screening
Vision screening with Spot Vision Screener
Measured: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Bone density measurement
Measured: 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
Measured: 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.
Measured: Corrected age/ chronological age of 6 months and 1 year
Weight
Measured: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Length
Measured: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Head circumference
Measured: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start12 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu Xuemei, Principal investigator, International Peace Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925360
- Sponsor's protocol ID
- GKLW-A-2024-114-01
- Status last verified
- Nov 2025
- First submitted
- 20 Mar 2025
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No