跳至主要内容
临床试验/NCT03258957
NCT03258957已完成不适用

Pilot Study of the Feasibility of Feeding Preterm Infants With Fresh Versus Frozen Mother's Own Breast Milk in the NICU

Huiqing Sun1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Feasibility of fresh breast milk

研究概览

简要总结

Necrotizing enterocolitis (NEC) is a severe inflammatory disorder of the intestine that primarily affects very low birth weight (<1,500 g)/very preterm infants (≤32 weeks' gestation); it is also the leading cause of death in the neonatal intensive care unit (NICU).Perhaps the best form of treatment for NEC is prevention. Mother's breast milk is best for preventing NEC. Breast milk contains both nutritional components (proteins, amino acids, fats, carbohydrates, vitamins, and minerals) and bioactive components (macrophages, T cells, cytokines, hormones, and growth factors) that have antimicrobial and anti-inflammatory properties.The current NICU breast milk feeding procedure exists as a means of ensuring that infants have consistent access to their mother's breast milk even if the mother is not able to spend time in the NICU. The process also allows for stricter quality and infection control, as well as computerised inventory and monitoring via electronic health records.However, the process deprives infants of the benefits of the cellular content of breast milk, including the stem cells.The primary objective of this study isto evaluate the feasibility and safety ofproviding very preterm infants (born at <30 weeks' gestation) with fresh milk (within 4 hours of expression).While we acknowledge that as a pilot the study will not be powered to detect a statistically significant difference, our secondary objective is to identify if this approach has the potential to improve infant outcomes, particularly with regards to the occurrence of NEC.

Our hypothesis is that it is feasible for many mothers to provide at least 1 feed of fresh breast milk (<4 hours post expression per day, and is not frozen, chilled or pasteurized) and that this may decrease the prevalence of NEC

详细描述

Background Necrotizing enterocolitis (NEC) is a severe inflammatory disorder of the intestine that primarily affects very low birth weight (<1,500 g)/very preterm infants (≤32 weeks' gestation); it is also the leading cause of death in the neonatal intensive care unit (NICU). The incidence of NEC (≥stage 2) in very preterm infants across Canada is 5% and increases as gestational age at birth decreases, with an incidence of 13% in infants born at <25 weeks' gestation and 10% in infants born at <29 weeks' gestation. Overall mortality from the disease has been reported to range from 15 to 30%, with more severe cases of NEC having a higher mortality rate.For infants who survive there is a significant risk of long-term complications and morbidity including neurodevelopmental issues.

Currently there is no known effective treatment for NEC. Infants are initially managed medically through bowel rest (cessation of oral feeds), abdominal decompression, administration of broad spectrum antibiotics, and provision of supportive care including parental nutrition, ventilator support, and blood transfusions as necessary. Should bowel perforation occur then surgery is required to remove damaged tissue and gas build up through laparotomy and/or primary peritoneal drainage.

Perhaps the best form of treatment for NEC is prevention. Mother's breast milk is best for preventing NEC. Breast milk contains both nutritional components (proteins, amino acids, fats, carbohydrates, vitamins, and minerals) and bioactive components (macrophages, T cells, cytokines, hormones, and growth factors) that have antimicrobial and anti-inflammatory properties. More recently, Hassiotou4 showed that breast milk is also a rich source of pleuripotent stem cells that when ingested by the infant, enter the blood stream and are incorporated into major organ systems in the infant. Although their function is unknown, it is possible that they benefit the infant through growth or regeneration. The evidence strongly suggests that fresh breast milk may have a protective effect against both infection and NEC. When mother's own breast milk is not available the options are donor breast milk or formula. The use of formula in low birth weight/preterm infants has been reported to increase the risk of developing NEC when compared with donor breast milk.

However, current practices related to handling and use of human milk raise questions about whether we are deriving maximum benefit from their use. Currently, in the standard neonatal intensive care unit (NICU) breast milk expressed by mothers of preterm infants is frozen and stored in the milk bank. When the infant requires oral feeds an order is placed with the milk bank, the oldest batch of milk defrosted, fortifier added as needed, and the milk then sent to the NICU for use. The act of freezing breast milk,either at -20°C or -80°C, along with the passage of time decreases the energy content and reduces the levels of several of the most useful components in the milk, including fat, carbohydrate,secretory immunoglobulin A,lactoperoxidase,lysozyme, antibacterial factors,and antioxidants. In addition to the decrease in these components, any stem cells in the milk have a half-life of 4 hours, so the defrosted milk does not contain any stem cells.

The current NICU breast milk feeding procedure exists as a means of ensuring that infants have consistent access to their mother's breast milk even if the mother is not able to spend time in the NICU. The process also allows for stricter quality and infection control, as well as computerised inventory and monitoring via electronic health records.However, the process deprives infants of the benefits of the cellular content of breast milk, including the stem cells.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Hour 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Eligible infants will include those born at <30 weeks gestation,and who have never received infant formula. For inclusion in the intervention group, the mother must bewilling to commit to providingat least 1 feed of fresh breast milk a day, 7 days a week

排除标准

  • Infants with major congenital anomalies, receiving palliative care, or where illness of the mother or infant prevents the administration of breast milk feeds in the first week of the infant's life will be excluded from the trial

研究组 & 干预措施

Fresh milk group

Experimental

In the intervention group, mothers will be asked to provide at least 1 feed of fresh milk (i.e. within 4 hours of milk expression) per day.Other time, feed frozen milk.

干预措施: Fresh Milk (Other)

结局指标

主要结局

Feasibility of fresh breast milk

时间窗: 3 year

Feasibility as defined by the percentage of mothers who can provide at least 1 feed of fresh milk a day from study enrollment until the infants are 32 weeks CGA

次要结局

  • sepsis(3 year)
  • Growth(3 year)
  • Mortality(3 year)
  • Bronchopulmonary dysplasia(3 year)
  • NEC(3 year)
  • Retinopathy of prematurity(3 year)

研究者

发起方
Huiqing Sun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Huiqing Sun

The director of neonatal intensive care unit

Zhengzhou Children's Hospital, China

研究点 (1)

Loading locations...

相似试验

Pilot Study of the Feasibility of Feeding Preterm... | 临床试验