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临床试验/NCT01739114
NCT01739114已完成不适用

Sustained Inflations to Achieve Lung Aeration at Birth - a Randomized Control Trial

University of Alberta2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
2
主要终点
Difference in bronchopulmonary dysplasia

研究概览

简要总结

To determine if respiratory support at birth guided by RFM decreases BPD.

详细描述

Despite recent advances in perinatal-neonatal care, there is an increasing trend of bronchopulmonary dysplasia (BPD) among survivors of prematurity1. Most infants developing BPD are born prematurely, and 75% of affected babies weigh less than 1000g at birth2. The risk of developing BPD increases with decreasing birth weight with reported incidence as high as 85% in neonates weighing between 500g and 699g, but only 5% in infants with birth weights over 1500g2. Alberta has the highest rate (10%) of delivering premature infants in Canada. In Edmonton approximately 200 premature infants <1250 g birth weight are born annually and up to 50% will develop BPD. This puts a heavy burden on health resources since these infants require frequent hospital re-admission in the first two years after birth and, even as adolescents have persistent respiratory symptoms.

Hypothesis Preterm infants <33 weeks gestation requiring breathing support at birth, the delivery of SIs (SI group) before mask ventilation compared to standard mask ventilation (IPPV group) will reduce the incidence of BPD.

Aim To determine if respiratory support at birth with initial sustained inflation compared to IPPV decreases BPD.

Study population Entry criteria Infants <33 weeks gestation born in the Royal Alexandra Hospital who require respiratory support for resuscitation in the delivery room.

Exclusion criteria Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, e.g. congenital pulmonary or airway anomalies, congenital diaphragmatic hernia, or congenital heart disease requiring intervention in neonatal period. Infants will also be excluded if their parents refuse to give consent to this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 30 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Infants <33 weeks gestation born in the Royal Alexandra Hospital who require respiratory support for resuscitation in the delivery room.

排除标准

  • Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, e.g. congenital pulmonary or airway anomalies, congenital diaphragmatic hernia, or congenital heart disease requiring intervention in neonatal period. Infants will also be excluded if their parents refuse to give consent to this study.

结局指标

主要结局

Difference in bronchopulmonary dysplasia

时间窗: 36 weeks corrected gestational age

Difference in bronchopulmonary dysplasia as defined by need for oxygen or respiratory support at 36 weeks corrected gestational age.

次要结局

  • Neonatal death < 28 days(< 28 days)
  • Death before discharge(before discharge from the NICU)

研究者

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

Georg Schmolzer

Research Neonatologist, Postdoctoral Fellow

University of Alberta

研究点 (2)

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