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临床试验/NCT01236599
NCT01236599已完成不适用

Comparison of Polyethylene Wrap With and Without Previous Drying in Preterm Infants: A Randomized Clinical Trial.

Instituto Mexicano del Seguro Social1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年8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
90
试验地点
1
主要终点
Corporal temperature of preterm infants and Temperature of the incubator.

研究概览

简要总结

The purpose of this study is to compare the response of temperature adaptation in preterm infant using the polyethylene wrap with and without previous drying.

详细描述

Preterm infants (PI) are predisposed to loss heat and have little subcutaneous tissue and a high ratio between surface and body weight and a reduced amount of glycogen deposits and brown fat (Gomella, 2005, p. 43).

In Mexico and South America in 2003 were reported 207.753 neonatal deaths, 21.4 per every 1,000 born alive in whom hypothermia was significant among infants with low birth weight and preterm infants. (Zuleta, Gomez & Jaramillo, 2009).

PRETERM INFANT Official Mexican Norm -007-SSA2-1993 (1995) considers a preterm infant as the product of the conception from 28-37 weeks of gestation, and weighing 1000-2499 g.

THERMOREGULATION OF PRETERM INFANT Survival of the newborn increases if the excessive loss heat is prevented. To achieve this purpose the newborn should be kept in a thermal environment neutral "which is what allows an infant consume the least amount of energy to maintain normal body temperature". (Karlsen, 2006, p. 49) The heat is gained or lost by convection 37% (between a child and a fluid: air stream or during bathing), conduction 4% (between two bodies in contact with different temperatures: the fields, mattress) radiation, 43% (between two solid surfaces that are not in touch: cool walls of the incubator) and 16% evaporation (heat loss in the conversion of water from liquid to gas, skin, breathing, sweating). (Tamez & Pantoja, 2004, pp. 29-30; Ruíz, 2007) The understanding of these forms of heat exchange provides the scientific basis for nursing interventions aimed at modifying the environment.

Response to cold stress of preterm infant: When the sensors of central and peripheral temperature detect stress for cold, they send signals to the hypothalamus. The hypothalamus activates the liberation of norepinephrine. This hormone causes increment in the metabolism, which increases the oxygen consumption and glucose utilization. The increment in the consumption of oxygen can induce hypoxemia and if it is severe, could progress to hypoxia. Peripheral vasoconstriction is limited in infant of very low birth weight in the first 48 hours of life; this increases the heat loss to level of the skin. In the preterm infant the loss heat occurs faster than its ability to produce and conserve heat. (Karlsen, 2006, p. 56) Adverse effects of cold stress in term and preterm neonate: When a term or a preterm neonate is hypothermic, the metabolism, oxygen consumption and glucose utilization increase. If the neonate, is experiencing trouble for breath, he will not be able of confront the increment in the demand of oxygen for tissues. This allows or increases the hypoxemia, which contributes to increased pulmonary vasoconstriction. The severe hypoxemia can progress to hypoxia, which leads to anaerobic metabolism. During anaerobic metabolism, the accumulation of lactic acid and blood ph drops is observed. If it is not reversed, the risk of death is high. (Jasso, 2005, p. 91; Karlsen, 2006, p. 58) The hypothermia can cause hypoglycemia, since the glucose is the primary source energy for the brain. The level of conscience of the neonate can diminish, the respiration can become slow and oxygenation will be affected. The survivors to an event of hypothermia have collateral effects as the increase of the difficulty of respiration, severe renal failure, disseminated coagulation, increase in the incidence of infection and persistence of the arterial conduit. (Karlsen, 2006, p. 58) PLACEMENT OF POLYETHYLENE BAG The program STABLE (sugar, temperature, airway, blood pressure, lab work and emotional support) for care post-resuscitation and pre-transport of sick neonates, recommended cover to premature infant with a plastic cover immediately after birth, from the neck down to reduce heat loss through evaporation and convection. (Karlsen, 2006, pp. 51, 53) The polyethylene bag, "is a cheap device, practical, simple, does not interfere with the immediate care or resuscitation (Vohra et al., 2004) and does not put in risk the integrity and security of the newborn. But it is not clear whether its effectiveness is similar with or without prior drying of the newborn, because the only study comparing these two techniques was conducted in term infants and it was not randomized (Menesses et al., 2002).

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
28 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Preterm Infant were included according with the Official Mexican Norm -007-SSA2-1993 (1995)

排除标准

  • •Preterm Infant were not included in case of malformations that involved lost of the cutaneous integrity or in case of severe cardiac congenital disease.

研究组 & 干预措施

traditional care

No Intervention

Preterm Infants were placed under a radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel), dried off and wrapped up in a sterile preheated field

干预措施: Polyethylene for thermoregulation in the preterm infant (Other)

Polyethylene bag with previous drying

Experimental

infants were placed under the radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel), dried off, and wrapped up in a polyethylene bag, leaving their faces discovered as well as the access at umbilical catheters or veined access.

干预措施: Polyethylene for thermoregulation in the preterm infant (Other)

Polyethylene bag without previous drying

Experimental

Preterm infants were placed under a radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel) and without previous body drying (only the head was dried), were wrapped up with the polyethylene bag, leaving their faces discovered as well as the access to umbilical catheters or veined access

干预措施: Polyethylene for thermoregulation in the preterm infant (Other)

结局指标

主要结局

Corporal temperature of preterm infants and Temperature of the incubator.

时间窗: every 15 minutes until the two hours of extrauterine life

Corporal temperature. An axillary thermometer of mercury was used, which was placed in the boy's armpit, making sure that it was in contact with the skin, during five minutes. Temperature of the incubator. It was directly registered from the incubator thermometer (medix TR 306). All the incubators started with a temperature of 34oC, and they were adjusted according to the necessity of preterm infant, when valuing the axillary temperature.

次要结局

  • Gestational age(. It was valued at birth by Capurro's score)
  • Weight(It was valued at birth)
  • Apgar score(the minute and the five minutes of life)
  • Heart rate(It was valued at birth and every 15 minutes until the two hours of extrauterine life)
  • Breathing frequency(. It was valued at birth and every 15 minutes until the two hours of extrauterine life.)
  • Capillar glucose(. It was measured at birth and at two hours of extrauterine life)
  • Environmental temperature(It was registered at birth)
  • Blood pressure(. It was measured at 15 minutes, one hour and two hours of extrauterine life)

研究者

申办方类型
Other Gov

研究点 (1)

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