Does Oral Care With Mother's Colostrum Reduce the Risk of Late-Onset Sepsis in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of infants with late-onset sepsis in each group
研究概览
简要总结
This clinical trial aimed to evaluate the efficacy of the oral mother's colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit. The investigators hypothesized that premature infants who receive oral mother's colostrum would have a lower incidence of late-onset sepsis and better hospital outcomes, compared to infants who receive a placebo.
详细描述
The study was a randomized clinical trial, performed on very-low-birthweight premature newborns admitted to the neonatal intensive care unit of Mataria Teaching Hospital after considering exclusion criteria.
The enrolled newborns were randomly subdivided into two groups (1:1). The colostrum group received their mother's colostrum, and the placebo group received placebo (sterile water) using a standardized protocol. The newborns received 0.2 mL of the colostrum or placebo orally using a swab directed backward into the oropharynx (0.1 mL on either side of the oral cavity), starting during the first 24 hours of life and lasting for 5 days. Vital signs were carefully monitored throughout the procedure. Dosing was provided every 6 hours during the study period.
All infants underwent follow-up from birth until discharge or death whichever came first. Neonates were evaluated for occurrence of late-onset sepsis, death, and other clinical outcomes.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Hour 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very-low-birth-weight preterm newborns admitted to the neonatal intensive care unit within 24 hours after delivery
- •Neonates with gestational age ≤ 34 weeks and weight ≤ 1500 grams
排除标准
- •Infants with severe gastrointestinal malformations.
- •Infants with serious congenital anomalies or chromosomal abnormalities.
- •Infants with signs of early-onset sepsis.
- •Any contraindications for breastfeeding because of maternal conditions including active tuberculosis or AIDS, or treatment with medications excreted in breast milk.
结局指标
主要结局
Number of infants with late-onset sepsis in each group
时间窗: Up to 40 weeks corrected gestational age
Positive blood cultures collected or clinical symptoms of sepsis after 72 hours of age
次要结局
- Mortality(Up to 40 weeks corrected gestational age)
研究者
Marwa Taha, MD
Fellow of Pediatrics (Principal Investigator)
General Organization for Teaching Hospitals and Institutes