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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA [Срок оценки: 36 weeks of postmenstrual age]

Вторичные конечные точки (8)

• duration of respiratory support [Срок оценки: until first discharge home or 36 weeks PMA]
• Preterm birth complications [Срок оценки: until first discharge home or 36 weeks PMA]
• Neurodevelopmental assessment [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
• Weight [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
• Length [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
• Head circumference [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
• Tidal Breathing Flow-Volume Curve Parameters [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
• Composite Clinical Assessment of Pulmonary Function Status [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• International Peace Maternity and Child Health Hospital — Шанхай

Идентификаторы

NCT: NCT07561125 · GKLW-A-2026-032-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗