Effect of Early Oral Colostrum Administration Versus Placebo on the Immune System in Premature Newborns Under 32 Weeks of Gestation: A Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Quantification of serum Immunoglobulins
研究概览
简要总结
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo
详细描述
Prematurity is a public health problem because premature newborns have an immature immune system. Breast milk (colostrum) contains bioactive components that provide antimicrobial, anti-inflammatory, antioxidant, and immunomodulatory functions. These bioactive components are in higher concentrations in mothers' colostrum of premature babies. Because of the morbidities presented by premature infants, they remain fasting and lack the potential benefit provided by colostrum. When the colostrum is placed in the oropharyngeal mucosa, the immunocompetent cells stimulate the immune system, increasing the serum concentrations of immunoglobulins.
Objectives: To determine the efficacy of early administration of colostrum in the oropharyngeal mucosa in preterm infants less than 32 weeks of gestation and its effect on the immune system by quantifying immunoglobulins in preterm infants born at the National Institute of Perinatology. .
Methods / Design: 1 year, double blind randomized controlled clinical trial. The newborns included will be randomly assigned to one of the 2 groups: Group 1:, newborns receiving colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.
Newborns from Block B will receive orally sterile water (placebo) 0.3 mL following the same protocol. Serum immunoglobulin A, M and G concentrations will be determined before the start of the study on day 0 of life and after 7 and 28 days of life. They will continue in time until 36 SDG or at discharge, whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Masking Description: The colostrum and placebo will be preparing by a Human Milk Bank person, who will be knowing the treatment of both 2nd and 1st group. Both colostrum and placebo, will be administrating by nursing staff in syringes in such a way that it is not detected that it contains each of them. Neither the parents of the participants nor the researchers will be involved in the care or analysis of the data, until the end of the study.
入排标准
- 年龄范围
- 12 Hours 至 36 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NEWBORN 32 Gestational weeks
- •Hospitalized in neonatal intensive care Unit
- •Agreement signed by the legal representative
排除标准
- •Intraventricular haemorrhage II/IV grade
- •Congenital sepsis (early sepsis)
- •Congenital malformations
- •Early transfusions
研究组 & 干预措施
Colostrum
Group 1:(Colostrum): Preterm infants under 32 SDG will receive orally colostrum 0.3 mL every 4 h during three days.
干预措施: Orally Colostrum (Biological)
Placebo
Group 2: (Placebo): Preterm newborns under 32 SDG who will receive orally sterile water 0.3 mL every 4 h during three days.
干预措施: Orally Colostrum (Biological)
结局指标
主要结局
Quantification of serum Immunoglobulins
时间窗: From baseline to day 7
Quantification of immunoglobulins IgA, IgG and IgM
次要结局
- sepsis neonatal(28 days of postnatal age)
- Quantification of serum Immunoglobulins(From baseline to day 28)
- Necrotising Enterocolitis(28 days of postnatal age)
研究者
Silvia Romero-Maldonado
NEONATOLOGIST
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes