Effects of an Exclusive Human Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Time to full enteral feeding
研究概览
简要总结
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).
详细描述
Infants born with congenital gastrointestinal disorders (CGD) can be very challenging to treat. The CGD require surgery shortly after birth to correct the problems and recovery can take a long time.
During the period of time the infant's intestines are sick or don't work properly, they rely on parenteral nutrition (IV fluids containing carbohydrates, proteins and fats) to meet their nutritional needs. Being on PN for a long time requires special intravenous lines, and increases the risk of blood stream infections and can make the liver sick.
Feeding babies who have these CGD is often very difficult, as the intestine needs to adapt. It needs to make appropriately formed stool to eliminate wastes, but not lose too much water or too many electrolytes. There is often a lot of starting and stopping of feeds. Human milk (HM) is considered the ideal source of nutrition for all infants.
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to participating NICU at less than 7 days of age
- •Birthweight >1250g and/or gestational age at birth >32 weeks
- •Less than 7 days of enteral feedings
- •Diagnosis of eligible primary "Congenital Gastointestinal Disorders" defined as: gastroschisis, omphalocele and intestinal atresias
- •Consent to the use of donor human milk products
- •Consent to participate in this study
排除标准
- •Admission to participating NICU at >7 days of age
- •Birthweight <1250g and/or gestational age <32 weeks
- •Diagnosis of non-eligible gastrointestinal disorders: congenital diaphragmatic hernia, midgut volvulus, Hirschsprung's disease, esophageal atresia, imperforate anus
- •Evidence of significant liver dysfunction at time of enrollment (direct bilirubin >4 and transaminases elevated more than 2 SD above upper limit of normal for age)
- •Liver malformations such as biliary atresia and choledochal cyst
- •Refusal of consent
研究组 & 干预措施
Retrospective Control Group
Approximately 150 patients with congenital gastrointestinal disorders who were treated in the neonatal intensive care unit (NICU) at Children's Healthcare of Atlanta-Egleston and other participating institutions from 2012 to 2015, who had non-human milk (HM) diets will be identified as retrospective controls using the electronic medical records system.
Exclusive Human Milk Diet Group
A minimum of 150 patients with CGD admitted to participating NICUs who meet inclusion criteria and provide informed consent will be enrolled in the prospective arm of the study. These patients will be fed an EHMD comprised of mother's own milk (MOM) or pasteurized donor human milk (DM). Fortification will be provided with human milk derived human milk fortifier, either a human milk-based fortifier (Prolact+ H2MF®) for infants born at less than 37 weeks GA or <2,200g birth weight or the term-equivalent version (PBCLN-002) formulated for infants >37 weeks and/or >2,200g at birth. Infants will receive this EHMD until they have achieved full enteral feedings for 7 days with bowel in continuity
干预措施: Human Milk (Other)
结局指标
主要结局
Time to full enteral feeding
时间窗: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
The number of days to achieve full enteral feeding after the initial human milk feeding
次要结局
- Number of days of parenteral nutrition(Through study completion, up to 1 year)
- Growth(Through study completion, up to 1 year)
- Difference in conjugated bilirubin levels(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
- Length of hospital stay(Through study completion, up to 6 months)
- Feeding interruptions(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
- Death rate(Through study completion, up to 1 year)
- Feeding intolerance(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
- Episodes of Necrotizing Enterocolitis(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
- Number of sepsis episodes(From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days))
研究者
Heidi Karpen
Assistant Professor
Emory University