IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

Официальное название

The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia

Обзор

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.

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 (11)

• 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.]
• Pulmonary function testing [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
• Vision screening [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
• Bone density measurement [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
• Blood routine tests [Срок оценки: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
• Rehabilitation evaluation [Срок оценки: Corrected age/ chronological age of 6 months and 1 year]
• 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]

Критерии участия

Критерии включения

• 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.

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: NCT06925360 · GKLW-A-2024-114-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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