IVIG for bronchopulmonary dysplasia in infants born at 28 weeks or earlier

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

This trial will try intravenous immunoglobulin (IVIG) given over five days to see if it helps very preterm infants (≤28 weeks) who show early signs of bronchopulmonary dysplasia.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 1 Day to 10 Weeks
• Sex: All
• Sponsor: International Peace Maternity and Child Health Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07561125 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, single-center interventional trial testing a five-day IVIG regimen in extremely preterm infants with suspected early bronchopulmonary dysplasia. Participants are infants born at ≤28 weeks + 6 days who are admitted within 24 hours and have respiratory symptoms plus chest X-ray findings consistent with early BPD. The dosing schedule is 1 g/kg/day as a continuous infusion for the first two days followed by 0.5 g/kg/day for the next three days (total 3.5 g/kg), with the course repeatable if clinically required. The study will monitor short-term and long-term safety and measures of respiratory support and lung outcomes.

Who should consider this trial

Good fit: Infants born at or before 28 weeks + 6 days, admitted within 24 hours of birth, with early respiratory distress and chest X-ray changes suggesting BPD and without major congenital anomalies are ideal candidates.

Not a fit: Infants with major congenital anomalies, other primary non-BPD causes of respiratory failure, or those born after 28 weeks are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, IVIG could reduce the severity of BPD and the need for prolonged respiratory support in extremely preterm infants.

How similar studies have performed: Use of IVIG specifically for treating or preventing BPD is relatively novel with limited prior evidence; IVIG has been used in neonates for infection-related indications but has not been proven to prevent or treat BPD in large definitive trials.

Eligibility criteria

Inclusion Criteria:

* Gestational age ≤ 28 weeks + 6 days
* Admission within 24 hours after birth.
* Infants show a suspicion of BPD, the diagnosis is suspected based on the following clinical manifestations and chest X-ray findings.

Clinical manifestations: Respiratory symptoms such as tachypnea (rapid breathing) and cyanosis, requiring respiratory support (including invasive, non-invasive, or oxygen therapy) to maintain oxygen saturation.

Chest X-ray: Findings include increased bilateral lung markings or ground-glass opacities, and diffuse increased density in both lungs. Other possible causes such as infection or heart disease should be 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

Where this trial is running

Shanghai

• International Peace Maternity and Child Health Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Fu Xuemei — International Peace Maternity and Child Health Hospital
• Study coordinator: Fu Xuemei

Conditions Bronchopulmonary Dysplasia