跳至主要内容
临床试验/NCT05511233
NCT05511233尚未招募不适用

OutComes of Implementing EnhAnced Recovery AftEr Intestinal Surgery Protocol in Newborns: CARES Study

Izmir Katip Celebi University0 个研究点目标入组 42 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
42
主要终点
Length of Stay

研究概览

简要总结

Aim: To determine whether the enteral feeding time and the type of the nutrient (according to the ERAS Recommendations) have any effect on LoS, complications, body weight gain, time until oral feeding, and time until first stool who have undergone intestinal surgery.

Design: A blinded, retrospective, randomized controlled trial. Setting: One-centred. Participants: Newborns who had intestinal surgery in the Ege University Faculty of Medicine Hospital Neonatal Surgery Intensive Care Unit and whose records can be accessed retrospectively from the electronic health records will be included. Those whose early enteral feeding initiation is contraindicated will not be included in the study.

详细描述

Every year, approximately 1.7 million children, most of them in low- and middle-income countries, are deprived of safe and evidence-based surgical and anaesthesia practices in the world, resulting in lifelong disability or mortality. The care of children who have undergone surgery, and especially newborns, has different physiological and sociological difficulties compared to adults. Newborns make up a particularly complex patient population due to their blood volume, temperature imbalance, immature immune systems, nutritional needs for growth and recovery, and inability to communicate. Therefore, guidelines have been developed to improve perioperative care and recovery through research, education, supervision and implementation of evidence-based practices in newborns. One of these guidelines is Perioperative Care in Neonatal Intestinal Surgery by Enhanced Recovery After Surgery® (ERAS) Society. In this guideline, there are recommendations on surgical practices, antimicrobial prophylaxis, hypothermia, perioperative fluid management, perioperative analgesia, optimal haemoglobin level, perioperative communication, postoperative nutritional care, mucous fistula refeeding and parental involvement. Among these recommendations, the initiation of early feeding (in the first 48 hours) is one of the core elements of nursing care. In patients who are not contraindicated such as necrotizing enterocolitis and volvulus, early feeding has effects on length of hospital stay (LoS), risk of wound infection, and increasing C-reactive protein levels. Although studies support this recommendation, different clinical conditions may require a delay in feeding, therefore, evidence for this recommendation was found to be weak in the guideline. Studies in different populations are needed to increase the strength of this recommendation. Also, the nutrient content is as important as the time of initiation of feeding, because thanks to its anti-infectious effect, it reduces the incidence of respiratory and gastrointestinal tract infections and necrotizing enterocolitis. Some studies have also shown neurodevelopmental advantages and a reduced incidence of metabolic disease. In addition, it has been determined that breast milk provides proper growth in newborns who have undergone surgery and prevents postoperative complications in babies who have had heart surgery. Therefore, in the ERAS protocol, it is recommended that the first preferred nutrient is breast milk. In the postoperative period, feeding intolerances can be seen in newborns as a complication because due to the operation, a dilated proximal segment may occur with hypoplasia of the smooth muscle or enteric nervous system, which leads to feeding intolerance. To prevent this complication, it is considered appropriate to use breast milk, which is a nutrient with high tolerability and can support intestinal adaptation thanks to its barrier function, probiotics and immunoglobulins it contains.

Design: A blinded, retrospective, randomized controlled trial. Setting: One-centred. Participants: Newborns who had intestinal surgery in the Ege University Faculty of Medicine Hospital Neonatal Surgery Intensive Care Unit and whose records can be accessed retrospectively from the electronic health records will be included. Those whose early enteral feeding initiation is contraindicated will not be included in the study.

Groups:

ERAS Group: Newborns who had breastmilk within the first 48 hours in the postoperative period will be in the ERAS group.

Control Group: Newborns who do not receive breast milk in the first 48 hours of the postoperative period will be in the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Newborns who had intestinal surgery in the Ege University Faculty of Medicine Hospital Neonatal Surgery Intensive Care Unit and
  • whose records can be accessed retrospectively from the electronic health records will be included.

排除标准

  • Those whose early enteral feeding initiation is contraindicated will not be included in the study.

结局指标

主要结局

Length of Stay

时间窗: 14 days

Time from surgery to discharge

first stool

时间窗: through study completion, an average of 14 days

time until first stool

first oral feeding

时间窗: through study completion, an average of 14 days

time until first oral feeding

full feed

时间窗: through study completion, an average of 14 days

time until full feed (120 ml/kg/day)

feeding intolerance

时间窗: through study completion, an average of 14 days

abdominal distention and repeated vomiting-more than three times a day

body weight gain

时间窗: through study completion, an average of 14 days

body weight gain

次要结局

  • the Accordion Severity Grading System of Surgical Complications Score(14 days)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ESRA ARDAHAN AKGUL

Assistant Professor, Principal Investigator

Izmir Katip Celebi University

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