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NCT Number: NCT06925360

IVIG Trial 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.

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Key information

Age range

Up to 10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Peng aiping

CONTACT

[email protected]

+86 021 64070434 ext. 50407

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. duration of respiratory support

    Time frame: until first discharge home or 36 weeks PMA

    Defined as cumulative days on assisted ventilation, support with oxygen, or both

  2. Preterm birth complications

    Time frame: until first discharge home or 36 weeks PMA

    Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al.

  3. Neurodevelopmental assessment

    Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years.

    Neurodevelopmental testing (e.g., Denver Developmental Screening Test)

  4. Pulmonary function testing

    Time frame: 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.

  5. Vision screening

    Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years

    Vision screening with Spot Vision Screener

  6. Bone density measurement

    Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years

  7. Blood routine tests

    Time frame: 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

  8. Rehabilitation evaluation

    Time frame: 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.

  9. Weight

    Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years

  10. Length

    Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years

  11. Head circumference

    Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

International Peace Maternity and Child Health Hospital

Other

Registry information

Official study title

The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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