Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Urinary Secretary IgA Concentration at 2 Weeks of Age
研究概览
简要总结
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Recent studies supports oropharyngeal administration as a potentially safe and effective delivery method for immunologic benefits and only small amount of colostrum could be administrated for immune therapy for extremely premature babies. The purpose of this study is to determine the beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in extremely low gestational age infants and evaluated the safety of this method to extremely premature infants in the first few days of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 48 Hours 至 96 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •premature infant with a gestational age less than 28 weeks born at Seoul National University Hospital and admit to the Seoul National University Children's Hospital NICU immediately after birth
- •parents of the infant signed to the informed consent form with voluntary agreement
排除标准
- •infants with major congenital anomalies or chromosomal syndromes
- •infants of mothers not willing to provide colostrum in the first week of life
- •infants of mothers with known infectious diseases that may be transmitted through the breast milk such as HIV, hepatitis C or active TB
研究组 & 干预措施
Colostrum
oropharyngeal administration of own mother's colostrum
干预措施: oropharyngeal administration of own mother's colostrum (Other)
Placebo
oropharyngeal administration of sterile water
干预措施: oropharyngeal administration of sterile water (Other)
结局指标
主要结局
Urinary Secretary IgA Concentration at 2 Weeks of Age
时间窗: 2 weeks of age
次要结局
- Concentration of Urinary Lactoferrin(1 week of age)
- In-hospital Death(up to 4 months of age)
- Urinary Secretary IgA Concentration at 1 Week of Age(1 week of age)
- Salivary TGF-beta 1 Concentration at 2 Week of Age(2 week of age)
- Salivary IL-8 Concentration at 2 Weeks of Age(2 weeks of age)
- Concentration of Urinary IL-1 Beta(2 weeks of age)
- Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines(2 weeks of age)
- Time to Reach Full Feeding(up to 2 months of age)
- Total Hospital Admission Duration(up to 4 months of age)
- Episodes of Culture Positive Sepsis(from date of randomization up to 4 months of age)
- Development of Intraventricular Hemorrhage ≥ Grade 3(up to 4 months of age)
- Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2(from date of randomization up to 4 months of age)
- Episodes of Pneumonia(from date of randomization up to 4 months of age)
- Development of Bronchopulmonary Dysplasia ≥ Moderate(up to 4 months of age)
- Development of Adverse Effects(from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age)
研究者
Han-Suk Kim
Professor
Seoul National University Hospital