Bronchopulmonary DysplasiaPhase 2NCT07561125
Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below
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 short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below. Read more about this study
- Who is it for?
- Ages 1 day 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
- 29 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 1 day to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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
Peng aiping, +86 021 64070434 ext. 50407, gfykyll@163.com
About this study
Official title: The Short-term and Long-term Effects of IVIG for Bronchopulmonary Dysplasia in Preterm Infant Born at 28 Weeks and Below
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.
- 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 | Drug: intravenous 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. 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 (8)
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) 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.
Measured: Corrected age/ chronological age of 6 months, 1 year, and 2 years
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
Tidal Breathing Flow-Volume Curve Parameters
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)
Measured: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Composite Clinical Assessment of Pulmonary Function Status
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.
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 posted1 May 2026
- Study start23 Apr 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (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
- 29 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
- NCT07561125
- Sponsor's protocol ID
- GKLW-A-2026-032-01
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term and Long-term Effects of IVIG for Bronchopulmonary Dysplasia in Preterm Infant Born at 28 Weeks and Below
- ClinicalTrials.gov ID
- NCT07561125
- Acronym / sponsor ID
- GKLW-A-2026-032-01
- Conditions
- Bronchopulmonary Dysplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVIG | Experimental | Drug: intravenous immunoglobulinDrug: intravenous 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. |
Who may qualify
- Ages
- 1 day to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous immunoglobulin1 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. | Drug | IVIG |
Primary outcome
Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA
Time frame: 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)
8 secondary outcomes
duration of respiratory support
Time frame: until first discharge home or 36 weeks PMA
Preterm birth complications
Time frame: until first discharge home or 36 weeks PMA
Neurodevelopmental assessment
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Weight
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Length
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Head circumference
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Tidal Breathing Flow-Volume Curve Parameters
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Composite Clinical Assessment of Pulmonary Function Status
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fu Xuemei principal investigator
International Peace Maternity and Child Health Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fu Xuemei (+86 18017313931, fxmzj2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA (time frame: 36 weeks of postmenstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.