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临床试验/NCT06593808
NCT06593808尚未招募不适用

SOon HOme Study. Early Open Cot Transfer in Preterm Infants, a Randomized Controlled Trial

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
82
试验地点
2
主要终点
Evaluation of average length of hospital stay of preterm infants

研究概览

简要总结

The goal of this randomized controlled trial without medication neither device (for procedure) is to compare the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams.

The main questions it aims to answer are:

  • Is it possible to reduce the average hospital stay in the early weaning group compared with the standard weaning group?
  • Is this procedure safe and without adverse outcomes between the two groups during the hospital stay and during the first week after discharge?

详细描述

Premature or low-birth-weight infants have low thermoregulatory abilities, higher risk of hypothermia and thus require a heated environment to survive. In the Neonatal Intensive Care Unit, these infants are placed from birth in an appropriately heated and humidified incubator. When they gain thermal competence they are gradually transferred to the open crib, normally when they reach a weight of about 1600-1800 grams, although the practice varies widely among neonatal units. Recent studies have concluded that clinically stable preterm infants can be transferred to an open crib at a body weight of less than 1600 grams. The abilities to maintain a normal body temperature in an open crib, good feeding autonomy, stable cardio-respiratory function, and acceptable growth rate are the physiological skills generally required for discharge of infants from the hospital.

The study compares the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams, as well as the incidence of adverse outcomes between the two groups (lower growth rate, inadequate breastfeeding, thermal lability and need for the incubator, readmission to the hospital) during the ward stay and during the first week after discharge, the degree of psychological stress of the parents, and the quality of the parent-child relationship in the two different groups.

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

性别
All
接受健康志愿者

入选标准

  • Infants with birth weight less than 1400 grams in incubator who have reached a minimum weight of 1400 grams
  • Stable clinical condition: normal heart rate and respiratory rate, No need for invasive respiratory assistance, no episodes of apnea, stable axillary temperature not less than 36.5°for at least 72 hours.
  • No need for phototherapy
  • Stable or increasing weight for at least 48 hours
  • Signature by both parents of an informed consent

排除标准

  • Severe congenital anomalies at birth
  • Need for invasive respiratory support at the time of enrollment
  • Ongoing phototherapy
  • Major surgical pathology with need for surgery
  • Failure by both parents to sign up for informed consent

结局指标

主要结局

Evaluation of average length of hospital stay of preterm infants

时间窗: 72 hours after weaning from the incubator

Compare the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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