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临床试验/NCT00769262
NCT00769262终止不适用

Effect of Conservative Weaning of Thermoregulatory Support on Weight Gain and Length of Stay in Preterm Neonates

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2008年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Length of hospital stay

研究概览

简要总结

Preterm newborns typically must be thermally regulated. In the United States, isolettes (incubators) are used to help them maintain their temperature. Traditionally, the temperature support (i.e. the temperature of the incubator) is decreased slowly according to NICU protocol until the baby is able to maintain its temperature in an open crib, without regard to the status of its feedings. This study will attempt to determine if there is a difference in length of stay, weight gain, and calories needed to gain appropriate weight between a group of newborns whose isolette temperatures are decreased in an aggressive strategy (isolette temperatures are decreased based only on baby's body temperature), and a group of newborns whose isolette temperatures are decreased in a conservative strategy (isolette temperatures are decreased to a minimum temperature and then kept steady until their feeds are at caloric goal and they are taking at least half of their feeds by mouth).

详细描述

General Background:

There are three key milestones premature infants must meet prior to discharge from the NICU:

  1. The ability to maintain their temperature in an open crib
  2. The ability to consume enough calories for adequate growth by oral feeds
  3. A demonstrated weight gain consuming these feeds.

It is well understood that infants must increase their resting metabolic rate when weaned from the isolette to an open crib (1, 6). Preterm neonates have less metabolic reserve (brown fat) to allow them to mount an appropriate thermogenic response to cold stress (4). The reserve they do have is often depleted at delivery, leaving them with little or no reserve (4). When a neonate is challenged to maintain its body temperature, it must increase heat production which may affect weight gain (3). Some institutions wean without regard to neonate's weight or feeding status, while others only begin the weaning process at a predetermined weight. Currently neonates are weaned from their isolettes based largely on the traditions and experiences of clinicians, without regard to their feeding status. However, there is currently very little evidence in the literature to inform practice on the ideal conditions for weaning a neonate from their isolette. An extensive literature review has revealed no published data regarding the relationship of feed status to success at isolette weaning.

The transfer to open crib is important; if the neonate is not able to maintain his/her temperature, the length of stay could be lengthened and weight gain adversely affected (3). Cold stress can also cause adverse clinical effects including lethargy, hypotonia, poor feeding, abdominal distention, vomiting, pallor, tachypnea, and respiratory distress (2). These adverse clinical effects may also lengthen cost and length of stay, as well as adversely affect feeding. Furthermore, a return to the isolette can be quite stressful to parents and family members (3).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Live born preterm infants from 26 and 0/7 weeks gestation to 34 and 6/7 weeks gestation
  • •Require thermoregulatory support
  • •Are able to take feeds
  • •Are presumed to be able to take oral feeds in the future

排除标准

  • •Preterm infants less than 26 and 0/7 weeks gestation
  • •Preterm infants greater than 34 and 6/7 weeks gestation
  • •Infants that do not require thermoregulatory support
  • •Infants that will not be able to have enteral feeds
  • •Infants with endocrine disease
  • •Infants with congenital anomalies
  • •Infants with grade 3 or 4 intraventricular hemorrhage or other severe neurologic disability
  • •Infants requiring long-term sedation
  • •Infants that die within 7 days of birth

研究组 & 干预措施

Aggressive Weaning

Active Comparator

Infants will be weaned from the isolette using our current NICU standard of care.

干预措施: Aggressive Weaning (Other)

Conservative Weaning

Experimental

Infants will be weaned from the isolette using a modified conservative weaning schedule.

干预措施: Conservative weaning (Other)

结局指标

主要结局

Length of hospital stay

时间窗: Hospital discharge

次要结局

  • Weight gain(When patient is on 120 cal/kg/day dietary intake)
  • Caloric requirement(When patient is changed to oral ad lib demand feeds)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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