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NCT Number: NCT07561125

Effects of IVIG for BPD 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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

1 day–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

International Peace Maternity and Child Health Hospital

Shanghai, 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 ≤ 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

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) 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.

  4. Weight

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

  5. Length

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

  6. Head circumference

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

  7. Tidal Breathing Flow-Volume Curve Parameters

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

    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)

  8. Composite Clinical Assessment of Pulmonary Function Status

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

    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.

Study contacts

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

Fu Xuemei

CONTACT

[email protected]

+86 18017313931

Li Dan

CONTACT

[email protected]

+86 18814100771

Sponsors and collaborators

Lead sponsor

International Peace Maternity and Child Health Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
May 1, 2026
Registry last updated
Jul 23, 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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