Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants：Effects on Secretory Immunoglobulin A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Change from Baseline in lactoferrin at 7 days
研究概览
简要总结
The purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low birth weight infants, to improve the utilization of breast milk and reduce infection rates of very low birth weight infants.
详细描述
The number of very low born weight infants increased every year.they are suffer from many questions.Recent studies have shown that Oropharyngeal administration of colostrum to very low birth weight infants can reduce the time reach full enteral nutrition .But there are no evidence support that it can promote infants' immune response. The hypothesis of the current study is that Oropharyngeal administration of colostrum to very low birth weight infants may increase the secretion of sIgA in urine and saliva.
The current study adopts randomized, double blind, controlled intervention trial, gives Oropharyngeal administration of colostrums to very low birth weight infants in intervention group and Oropharyngeal administration of Normal saline to control group. All indicators in this study are discrete traits, for sIgA、Lactoferrin number in Saliva and urine， number of CRP，time Begin oral feeding，time up to full enteral feeding， Person's chi-square tests were used for comparisons. For Blood culture results，The number of necrotizing enterocolitis (NEC) occurred， the investigators use Chi-square tests for comparisons between two groups. The study expects that Oropharyngeal administration of colostrum to very low birth weight infants can increase the secretion of sIgA in urine and saliva.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born weight≤1500g
- •transferred to our hospital within 24 hours after birth
- •the mother can provide colostrum
- •parents of the infants agreed to participate in this study
排除标准
- •The infants suffering from life-threatening conditions ,such as severe heart disease,whose survival time are expected <30d
- •The infants suffering from any kinds of disease,which impact they take human milk by mouth.(such as gastrointestinal malformations, NEC, etc.）
- •human milk is contraindicated
- •An infant whose mother :
- •Is infected with the human immunodeficiency virus (HIV)
- •Is taking antiretroviral medications
- •Has untreated active tuberculosis
- •Is infected with human T-cell lymphotropic virus type l or ll
- •Is using or dependent on an illicit drug except if the breastmilk is medically indicated
- •Is taking prescribed cancer chemotherapy agents contraindicated for breastfeeding
- •Is receiving any medications contraindicated in breast feeding
- •Is receiving diagnostic or therapeutic radioactive isotopes or exposure to radioactive materials (for as long as they are radioactive in the milk)
- •An infant diagnosed with galactosemia, a rare genetic metabolic disorder
结局指标
主要结局
Change from Baseline in lactoferrin at 7 days
时间窗: at baseline（first time baby in hospital） and at 7 days
in urine and saliva
Change from Baseline in lactoferrin at 21 days
时间窗: at baseline（first time baby in hospital） and at 21 days
in urine and saliva
Change from Baseline in sIgA at 21 days
时间窗: at baseline（first time baby in hospital） and at 21 days
in urine and saliva
Change from Baseline in sIgA at 7 days
时间窗: at baseline（first time baby in hospital） and at 7 days
in urine and saliva
次要结局
- The number of participants with necrotizing enterocolitis (NEC)(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- The duration from admission to the start of oral feeding(participants will be followed for the duration of hospital stay, an expected average of 3 days)
- The duration from the start of enteric feeding to full enteric feeding(participants will be followed for the duration of hospital stay, an expected average of 14 days)