Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
2014年8月11日 更新者：Han-Suk Kim、Seoul National University Hospital
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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
48
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Seoul、大韩民国、110-744
- Seoul National University Children's Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2天 至 4天 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Colostrum
oropharyngeal administration of own mother's colostrum
|
application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
|
|
安慰剂比较：Placebo
oropharyngeal administration of sterile water
|
application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Urinary Secretary IgA Concentration at 2 Weeks of Age
大体时间：2 weeks of age
|
2 weeks of age
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Urinary Secretary IgA Concentration at 1 Week of Age
大体时间：1 week of age
|
1 week of age
|
|
|
Salivary TGF-beta 1 Concentration at 2 Week of Age
大体时间：2 week of age
|
2 week of age
|
|
|
Salivary IL-8 Concentration at 2 Weeks of Age
大体时间：2 weeks of age
|
2 weeks of age
|
|
|
Concentration of Urinary Lactoferrin
大体时间：1 week of age
|
1 week of age
|
|
|
Concentration of Urinary IL-1 Beta
大体时间：2 weeks of age
|
2 weeks of age
|
|
|
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
大体时间：1 week of age
|
1 week of age
|
|
|
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
大体时间：2 weeks of age
|
2 weeks of age
|
|
|
Time to Reach Full Feeding
大体时间：up to 2 months of age
|
day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day
|
up to 2 months of age
|
|
Total Hospital Admission Duration
大体时间：up to 4 months of age
|
days from admission to discharge from NICU
|
up to 4 months of age
|
|
Episodes of Culture Positive Sepsis
大体时间：from date of randomization up to 4 months of age
|
numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)
|
from date of randomization up to 4 months of age
|
|
Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2
大体时间：from date of randomization up to 4 months of age
|
from date of randomization up to 4 months of age
|
|
|
Episodes of Pneumonia
大体时间：from date of randomization up to 4 months of age
|
numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics
|
from date of randomization up to 4 months of age
|
|
Development of Bronchopulmonary Dysplasia ≥ Moderate
大体时间：up to 4 months of age
|
up to 4 months of age
|
|
|
Development of Intraventricular Hemorrhage ≥ Grade 3
大体时间：up to 4 months of age
|
up to 4 months of age
|
|
|
In-hospital Death
大体时间：up to 4 months of age
|
up to 4 months of age
|
|
|
Development of Adverse Effects
大体时间：from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age
|
category of adverse effects
|
from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2012年1月6日
首先提交符合 QC 标准的
2012年2月15日
首次发布 (估计)
2012年2月20日
研究记录更新
最后更新发布 (估计)
2014年8月13日
上次提交的符合 QC 标准的更新
2014年8月11日
最后验证
2014年8月1日
更多信息
与本研究相关的术语
其他研究编号
- OAC-01-ELGAN
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