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临床试验/NCT05378685
NCT05378685Unknown不适用

The Effect of Oral Versus Nasal Intubation on Feeding Outcomes in Neonates Requiring Cardiac Surgery

University of Virginia2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Feeding method at discharge

研究概览

简要总结

Often, infants struggle to feed orally after surgery for congenital heart disease and may require supplemental feeding interventions at discharge. In this study, the investigators prospectively randomize infants to oral or nasal endotracheal intubation for surgery and assess postoperative feeding success.

详细描述

Patients who require cardiac surgery in the neonatal period frequently encounter difficulties reaching full volume oral feeds. These difficulties are related to developmental features, perioperative events, and post-operative oral aversion symptoms. Patients who struggle with oral feeding require longer hospitalizations and frequently require invasive devices for stable nutrition at discharge. The investigators hypothesize that nasal intubation for neonatal cardiac surgery may reduce time to full oral feeds and decrease the proportion of patients requiring discharge feeding tubes.

This is a single-center, prospective randomized control trial of patients less than 2 weeks of age who undergo endotracheal intubation at the time of cardiac surgery. The investigators exclude patients who were <37 weeks corrected gestational age (GA) at surgery, had orofacial or gastrointestinal anomalies, required >5 days of intubation before surgery, or required ECMO or >5 minutes of CPR at any time during the hospitalization. Patients are randomized to nasal (NI) or oral intubation (OI) by a trained pediatric cardiac anesthesiologist at the time of their surgery.

Infants are followed post-operatively until the time of discharge and otherwise receive routine care in the intensive care unit and acute cardiology service. Information regarding feeding milestones is obtained from the electronic medical record.

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

盲法说明

The intubation route (oral or nasal) is obvious and visible to everyone who interacts with the infant postoperatively.

入排标准

年龄范围
— 至 2 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants who require surgery for congenital heart disease before 2 weeks of age

排除标准

  • < 37 weeks estimated gestational age at the time of surgery
  • Orofacial or gastrointestinal anomalies
  • Devastating neurologic injury or malformation
  • Intubation > 5 days prior to surgery
  • > 5 minutes of CPR or ECMO at any time

结局指标

主要结局

Feeding method at discharge

时间窗: Approximately 1 month after surgery

Infants are discharged home either fed completely by mouth, fed by nasogastric tube (plus/minus some oral feeds), or gastrostomy tube (plus/minus some oral feeds).

次要结局

  • Time to full feeds(Approximately 1 month after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Yildirim, MD

Resident, Pediatrics

University of Virginia

研究点 (2)

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