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临床试验/NCT06731439
NCT06731439招募中不适用

Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?

University of Tennessee1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2024年6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
招募中
入组人数
248
试验地点
1
主要终点
Day of life reaching full feeds

研究概览

简要总结

Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds. ELBW infants initially remained NPO for several days before initiating trophic feeds. However, data then showed that there was no increase in mortality and morbidity if trophic feeds were initiated earlier. Then data showed that a short duration of trophic feeds did not increase mortality and morbidity when compared to a prolonged duration. More recent data showed that enteral feeding should be initiated early, preferably within 24 hours of birth, because it may promote feeding tolerance, shorten the time to reach total enteral feeding, and reduce the incidence of extrauterine growth restriction and late onset sepsis without increasing the risk of developing NEC. The management of enteral nutrition in ELBW infants is still very variable. For example, there is no consensus on the optimal time point after birth at which enteral nutrition can be started. This study evaluates the benefits of starting feeds by 6 hours of life Purpose: The primary aim of this study is to evaluate if in infants ≤ 1000g birth weight, is there a benefit initiating feeds by 6 hours of life (compared to current feeding practice data of 3 days of life) on decreasing the time to attain full feeds in the first 30 days of life. The secondary aim is to evaluate if antenatal feeding discussions would streamline feeding management post-delivery.

详细描述

Rationale: Although current evidence supports initiating enteral feedings as early as the first day of life in extremely low birth weight infants, there are two main barriers that are usually associated with the initiation of feeding not taking place until an average of the third day of life. Since it is common to supplement the infant's nutrition with donor breast milk, and since donor breast milk requires parental consent, the process of consenting is usually done after the infant is born. This would be the time when the parents are updated with the status of their child and the time when other consents are taken. For example, this would be the time to talk about and take consent for blood transfusions, central line placement, and donor breast milk supplementing the infant's nutrition. The mother is the one most commonly giving consent. In situations after cesarean section or after receiving pain medications, the mother is not in a state where she can be approached for consent. This is typically not an issue for interventions like blood transfusions and central line insertions as the need does not arise typically until after a few days. However, when it comes to enteral feeding, it is recommended to start feeding as early as possible. However, because of the previously listed reasons, this sometimes gets pushed further until the mother is in a more stable situation to approach her for consent.

Another important aspect of feeding pertains to what is considered feeding and what is considered gut priming. It is generally considered that enteral feedings of 10 ml/kg/day are not enough volume to be considered "feeding." This volume is considered more of gut priming that stimulates gut enzymes to get produced and starts the clock for the eventual advancement of feeds. For these initial 10 ml/kg/day volume feeds, the term minimal enteral nutrition has been commonly used. In patients to be enrolled in this study, this will come out to be an average of 0.75 ml every 3 hours, a volume that is typically less than the volume of gastric juice being internally produced by the infant. It is also a volume so small that it is not thought to lead to any significant negative sequelae.

On the other hand, research has shown that prolonged enteral fasting may diminish the functional adaptation of the immature gastrointestinal tract and extend the need for parenteral nutrition along with its risk of sepsis-related morbidity and mortality. Research has also shown that the initiation of early enteral feeds could release trophic endogenous agents and inhibit the release of inflammatory mediators and cytokines. It also assists with the development of the intestinal mucosa, activates digestive enzymes, and improves digestion and absorption to avoid the complications associated with vascular catheterization, sepsis, long-term fasting, and vascular alimentation.

There are no uniform guidelines of how fast to advance feeds in this premature infant population. Depending on the practice, it may take a premature infant 7-15 days to reach the 150 ml/kg/day target volume.

Starting feeds by 6 hours is expected to initiate the feeding process for premature infants and be associated with several benefits. The aim of this study is to investigate if finalizing nutritional care plans with the mother antenatally offers any clinically beneficial outcomes in either streamlining the nutritional care plan as a short-term outcome or being associated with beneficial long-term outcomes. This is currently not practiced because either there is not enough personnel or it is felt not of a high yield because the mother may not end up delivering and come back at another visit to deliver. The study would leverage that starting feeds by 6 hours of life is not considered unsafe because the volume of milk that would be given every 3 hours is <1ml. However, starting early would have helped the infant start the feeding advancement process. The focus is more on "starting" than on "feeding" since the volume received in the first 24 hours is not considered food as much as it is considered gut priming. In other words, the treatment arm group that will have their feeds started by 6 hours of age will have the benefit of having their nutrition clock started earlier when compared to the current standard of care.

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
None

入排标准

年龄范围
1 Minute 至 6 Hours(Child)
性别
All
接受健康志愿者
否

入选标准

  • •All infants less than or equal to 1000 g
  • •Clinical care team in agreement with patient's participation
  • •All mothers with pregnancies with EFW close to 1000g or less.

排除标准

  • •1 congenital malformations that may affect gastro intestinal perfusion
  • •2 Clinically progressing towards imminent death
  • •3 congenital gastrointestinal obstructions
  • •4 Mothers unlikely to deliver infants ≤ 1000g
  • •5 Infant on pressors other than dopamine given at < 5mcg/kg/min. Dopamine is an exclusion if administered at a dose exceeding 5mcg/kg/min.
  • •6 Mothers who are not in a sound mental state to be consented either to their critical condition, intubated, sedated, for examples
  • •7 Mothers who are critically ill where by it is felt that mom will not be able to participate in the consent

研究组 & 干预措施

Early feeding arm

Experimental

干预措施: Starting feeds within 6 hours of life (Other)

Control arm

Active Comparator

干预措施: Standard feeding protocol (Other)

结局指标

主要结局

Day of life reaching full feeds

时间窗: From birth until day of life full feeds reached in the first 30 days of life

The primary outcome is the age in days in the first 30 days of life when the infant reaches full feeds.

次要结局

  • Secondary Outcomes(From birth until hospital discharge)
  • Secondary Outcomes(From birth until 30 days of life)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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