Clinical and Economic Impact of Supplementation With Donor Milk Pasteurized by HTST Method Versus Holder Method in Extremely Birth Weight Preterm Infants. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 4
- 主要终点
- Microbiological proven late onset sepsis rate
研究概览
简要总结
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short Time (HTST) method versus the Holder method.
详细描述
Donor milk pasteurized by an innovative High Temperature Short Time (HTST) system (patented by researchers) retains more immune and trophic compounds than pasteurized milk by traditional Holder method. These compounds are related to the protection conferred by breast milk against nosocomial sepsis and necrotizing enterocolitis in preterm infants, so it would be of interest to study if there is a clinical benefit in these patients when health professionals are supplementing with donor milk pasteurized by both methods.
The purpose of this study is to compare the incidence of microbiological proven late onset sepsis in newborns under 1000 grams that in the first 28 days of life need to be supplemented with donor milk pasteurized by HTST method versus the Holder method.
This is a randomized double-blind clinical trial with parallel assignment. A total of 305 premature babies with a birth weight of less than 1000 grams will be recruited, admitted to the Neonatology Services of the Hospital 12 de Octubre and the Hospital de La Paz and meet the inclusion criteria. Half of the patients will be supplemented exclusively with donor milk pasteurized by the HTST system and the other half with pasteurized milk by the Holder method. Linear generalized models will be used for longitudinal data analysis.
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
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(all criteria are necessary) :
- •Infants weighing 1000 grams or less at birth
- •Infants born or transferred before the third day of life to the participating centers
- •Start enteral feeding in the first week of life
- •Receive any amount of donor milk in the first 28 days of life
- •Informed consent signed by parents or legal guardians
排除标准
- •Language barrier
- •Infants with chromosomopathies
- •Infants with major congenital malformations
- •Infants with severe asphyxiation (cord pH or first arterial pH <7)
- •Infants included in another clinical trial that modifies nutritional management
- •Infants who previously fed with formula
- •Post-randomization exclusion criteria:
- •Randomized infant who do not fulfill inclusion criteria
结局指标
主要结局
Microbiological proven late onset sepsis rate
时间窗: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Incidence of Microbiological proven late onset sepsis expressed as a percentage
次要结局
- Central line associated bloodstream infections (CLABSI) rate(From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks)
- Mortality rate(From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks)
- Growth velocity(Assessed up to 24 weeks)
- Necrotizing enterocolitis (NEC) and/or microbiological proven late onset sepsis rate(From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks)
- Oxygen supplementation(Assessed up to 24 weeks)
- Stage 3-5 Retinopathy(From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks)
研究者
Carmen Rosa Pallas
Head of Neonatology Service, MD, PhD
Hospital Universitario 12 de Octubre