跳至主要内容
临床试验/NCT02415049
NCT02415049已完成不适用

A Prospective Randomized Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy

Indiana University1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2014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
入组人数
163
试验地点
1
主要终点
Time to goal feeds

研究概览

简要总结

There are several choices to consider when determining the timing of initiation of enteral feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as the infant awakens from anesthesia. Some authors have suggested a period of withholding feedings for several hours postoperatively, while others have recommended a significantly longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises over whether a physician chooses a standardized, incremental feeding regimen versus an ad libitum feeding schedule which allows the infant to decide when and how much to eat. Neither has been studied effectively in a randomized controlled setting. A recent review of the literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be the best postoperative regimen. This however, has not been studied in a randomized, controlled trial.

详细描述

A. SUMMARY AND SPECIFIC AIMS B. RESEARCH DESIGN AND METHODS C. REFERENCES

SUMMARY AND SPECIFIC AIMS

Infantile hypertrophic pyloric stenosis is a condition well known to pediatric surgeons, and has been deemed "the most common cause for surgery in the first 6 months of life". This condition affects a large group of children annually with an incidence of 1.8 per 1000 births. Postoperative length of hospital stay is a financial concern and remains a potential target for reduction in hospital costs. Ultimately, these costs are directly affected by the ability to effectively advance postoperative enteral nutrition. Some experts calculated this savings to be $392.00 per patient while others estimate an impressive $1,290 saved per patient.

There are several choices to consider when determining the timing of initiation of enteral feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as the infant awakens from anesthesia. Some authors have suggested a period of withholding feedings for several hours postoperatively, while others have recommended a significantly longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises over whether a physician chooses a standardized, incremental feeding regimen versus an ad libitum feeding schedule which allows the infant to decide when and how much to eat. Neither has been studied effectively in a randomized controlled setting. A recent review of the literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be the best postoperative regimen. This however, has not been studied in a randomized, controlled trial.

The investigators therefore hypothesize that 1) infants provided with an ad lib diet following pyloromotomy will progress more rapidly to full volume feeds than infants provided an incremental advancement in diet, and 2) Preoperative blood chemistry abnormalities will predict increased emesis postoperatively.

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
None

入排标准

年龄范围
2 Weeks 至 10 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Subjects to be included in the study include infants who have a diagnosis of pyloric stenosis who will undergo pyloromyotomy.

排除标准

  • •Patients with severe underlying medical conditions including but not limited to hypothermia, sepsis, glycemic instability, or need for care in the intensive care unit/neonatal intensive care unit will not be included in the study.

研究组 & 干预措施

Incremental

Active Comparator

This arm of patients will be fed in the traditional standard of care manner following pyloromyotomy. They start with 15ml of pedialyte and advance by 15ml increments of formula or breastmilk to a goal of 100ml/kg/day

干预措施: Incremental Feeds (Other)

Ad-lib

Experimental

This arm of patients is fed ad lib following surgery and can feed with formula or breast milk at any time and with any frequency up to 12.5ml/kg/feed

干预措施: Ad lib feeds (Other)

结局指标

主要结局

Time to goal feeds

时间窗: 24-48 hours

We are measuring the time it takes for the child to reach goal feeds following surgery. (100ml/kg/day in incremental group, or 12.5ml/kg/feed in ad lib group)

次要结局

  • Parent satisfaction measured by satisfaction scale(24 hours to 1 week)

研究者

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

Troy Markel

Assistant Professor of Surgery

Indiana University

研究点 (1)

Loading locations...

相似试验