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Recruiting NCT07561125

Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below

Phase II Interventional Bronchopulmonary Dysplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intravenous immunoglobulin.
Who it may be relevant to
Registry conditions: Bronchopulmonary Dysplasia. Basic parameters: 1 Day — 10 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Short-term and Long-term Effects of IVIG for Bronchopulmonary Dysplasia in Preterm Infant Born at 28 Weeks and Below

Overview

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

  • 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.

Primary outcome measures

  • Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA [Time frame: 36 weeks of postmenstrual age]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • International Peace Maternity and Child Health Hospital — Shanghai

Identifiers

NCT: NCT07561125 · GKLW-A-2026-032-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗