Oropharyngeal Administration of Mother's Colostrum: Health Outcomes of Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 10
- 主要终点
- Incidence of necrotizing enterocolitis
研究概览
简要总结
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. The investigators hypothesize that infants who receive oropharyngeal mother's colostrum and milk will have significantly lower rates of infection and improved health outcomes, compared to infants who receive a placebo.
详细描述
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. This 5-year placebo-controlled, double-blind randomized controlled trial will evaluate the safety, efficacy and health outcomes of oropharyngeal administration of OMC/OMM in a sample of 622 (total patients enrolled) extremely premature infants with the following aims: Aim 1. To determine if oropharyngeal administration of OMC/OMM to extremely premature infants will reduce the risk of late-onset sepsis or death as the primary outcome, and necrotizing enterocolitis and ventilator-associated pneumonia as pre-planned secondary outcomes. Aim 2: To determine if extremely premature infants who receive OMC/OMM via the oropharyngeal route have a shorter time to reach full enteral feeds and a shorter length of hospital stay. Aim 3: To determine if oropharyngeal administration of OMC/OMM will have immunostimulatory effects for extremely premature infants, as measured by (A) enhancement of gastrointestinal (fecal) microbiota, (B) improvement in antioxidant defense maturation or reduction of pro-oxidant status, and (C) maturation of immunostimulatory effects as measured by changes in urinary lactoferrin. Results will confirm whether extremely premature infants demonstrate a host-immune response to this intervention and whether there is a beneficial effect on common morbidities in these high risk patients.
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
- 1 Day 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birthweight <1250g Mother plans to pump and provide breastmilk for at least 2 months Absence of severe congenital anomalies Admission to the neonatal intensive care unit within 24 hours after birth Ability to begin protocol within 96 hours of life
排除标准
- •Gastrointestinal anomaly pH < 7.0 on initial blood gas in NICU Maternal +HIV status Maternal drug or substance use that precludes infant from receiving mother's milk Tracheoesophageal fistula
结局指标
主要结局
Incidence of necrotizing enterocolitis
时间窗: at 40 weeks CGA
defined according to modified Bell's criteria stage \>2 with clinical signs and radiological evidence of pneumatosis intestinalis or portal venous gas
Incidence of ventilator-associated pneumonia
时间窗: at 40 weeks CGA
Incidence of of late-onset sepsis
时间窗: at 40 wks CGA
positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms
次要结局
- Time to reach full enteral feeds(at 40 wks CGA)
- Changes in stool microbiome(3 days, 2 weeks, 32 weeks CGA)
- Length of hospital stay(at 40 wks CGA)
- Concentrations of lactoferrin in urine(1 day, 3 days, 32 weeks CGA)
- Changes in urinary biomarkers of oxidative stress(3 days,)