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临床试验/NCT04351425
NCT04351425Unknown不适用

Feasibility and Safety of Earlier Weaning of Preterm Newborn From Incubator to Cot at 1400 Grams

King Fahad Medical City0 个研究点目标入组 61 人开始时间: 2020年4月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
61
主要终点
temperature control

研究概览

简要总结

Background: To maintain the body temperature of preterm newborns is one of the essential criteria for discharge from hospital.

Aim: we aimed to assess the feasibility and the safety of an early weaning protocol from incubator to unheated cot at 1400 g preterm newborns.

Methods: This was a randomized control trial with preterm neonates with birth weights < 1400 g conducted at King Fahad Medical City, Riyadh, Saudi Arabia. We compared newborns weaned to cot at a weight of 1400 g to newborns weaned at a weight of 1600 g. The outcome was to assess the feasibility of the protocol in terms of temperature control and average weight gain.

Results: A total of 23 preterm neonates were recruited in this study. The baseline characteristics were similar except for the gestational age was higher in the newborns enrolled to 1400 g group. Early weaning was achieved in 100% of newborns without significant adverse effects on temperature stability or weight gain. Incidence of low and high temperatures per newborn and the average weight gain before and after transfer and after transfer were not different between the two groups.

Conclusion: Our results showed the feasibility and safety of 1400 g weaning protocol for preterm newborns, without any adverse effects or increasing the neonatal length of hospital stay. Further investigations in larger patient groups are recommended.

详细描述

  1. Introduction To discharge a preterm newborn after staying in neonatal intensive care unit (NICU) is a multifactorial decision. According to the American Academy of pediatrics guidelines of the physiologic competencies for hospital discharge of the high-risk neonate including preterm ones, are sufficient oral feeding and mature respiratory control, and finally the ability to maintain a normal body temperature in an unheated open bed (1). These mostly are achieved between 36 and 37 weeks' postmenstrual age (2-4).

Shortening the period of a hospital stay, it could be beneficial to decrease the emotional stress resulted from the separation between the mother and the newborn and parents; furthermore, it may reduce the hospital-acquired co-morbidities as sepsis and surgical needs (5) and accordingly reduce the economic burden on the society.

The timing to wean from the incubator is crucial since the immaturity of preterm newborn's thermoregulatory mechanisms which could affect weight gain as an attempt to maintain body temperature, achieving full feeding volume, and as a result could delay discharge from hospital (6, 7). The target weight for incubator weaning varies widely among NICUs. The common usual practice is between of 1700-1800 g, and it is generally based on the professional experience and judgment (8, 9).

In 2010, a Cochrane Review assessed transferring preterm infants from incubator to open bed at a lower body weight (˂1700 g) by comparing to a higher body weight (˃ 1700 g). The review showed that preterm newborns can be transferred to open beds at 1600 g without adverse effects on temperature stability in terms of return to incubator or daily weight gain (10). A multicenter trial achieved the same result (11).

Moreover, there are few studies showed that infants can be successfully transferred into cots at weights down to 1500 g (9, 12). A pilot study carried out stepwise four cohort trials of newborn's transfer from incubators to open beds at 1800 g, then at 1700 g, then at 1600 g and then finally at 1500 g (13). It demonstrated that there were no significant differences between the four cohorts in maintain body temperature after incubator weaning.

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

盲法说明

Participants: randomly selected infants, group 1 less than 1400 kg, group 2 more than 1600 kg

入排标准

年龄范围
23 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical weight less than 1.5 kg at birth
  • Clinically stable
  • No cardio or respiratory support
  • Reached 2/3 of his/her enteral feeding

排除标准

  • Clinical unstable
  • On cardio or respiratory support
  • Dysmorphic

结局指标

主要结局

temperature control

时间窗: 1 month

Hourly axillary temperature was taken until two consecutive readings of between 36.4 and 37.1 C, after which temperatures were taken 3 times with each feed until at least 72 hours after transfer and after that a minimum of four times a day until discharge. If the axillary temperature is less than 36.4◦C, an additional wrap was added. If the temperature remained low, an hour later, the newborn was returned to an incubator. Failure to transfer was defined as the inability to maintained body temperatures in a cot despite additional covering, with two consecutive axillary temperatures below 36.4 ◦C, one hour apart. If the temperature more than 37.1C°, the wraps were reduced accordingly.temperature

daily weight gain

时间窗: 1 month

newborns were weighed naked daily as a routine NICU practice using electronic scales. The rate of weight gain was calculated as grams/kilogram per day over the week before and after transfer.

次要结局

未报告次要终点

研究者

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

Abdulrahman Al-Matary

Principal Investigator

King Fahad Medical City

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