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临床试验/NCT03464396
NCT03464396已完成不适用

Physiologic Biomarkers Predicting Ventilatory Instability and Hypoxemia in Pre Mature Infants

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2018年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
177
试验地点
1
主要终点
Respiratory phenotype based on physiologic testing

研究概览

简要总结

The purpose of this research study is to improve our understanding of unstable breathing and heart blood flow patterns seen in premature infants. The investigator will use novel non-invasive measures to understand the determinants of these unstable breathing and heart flow patterns to potentially identify new therapies for their prevention.

详细描述

The investigator will look at results of breathing tests, non-invasive sound wave (ultrasound) test of the heart and blood vessel (Echocardiography), and a sample of blood to see if it is possible for early detection of breathing control and lung blood vessel dysfunction (pulmonary vascular disease) in infants that are at risk for exposure to long term low oxygen levels. A subset of infants will have a magnetic resonance Imaging study (MRI) between 37- 40 weeks gestational age (GA) or at the time of discharge, whichever comes first.

Respiratory tests include:

  • Bedside Physiology Study completed at 28, 32, 36, 40, and 52 weeks GA in conjunction with the respiratory tests. A 90-minute recording will be made using standard recording equipment that includes a conventional pulse oximeter, an EEG, an airflow sampling catheter near the nose, and respiratory inductance plethysmography (RIP) bands. Standard bedside monitoring will continue during the physiologic studies
  • Carotid Body Function Test completed at 32, 36, 40 and 52 weeks GA. This test is to unmask respiratory instability in response to hyperoxia.
  • Challenge Test completed at 36 weeks GA.
  1. Infants receiving nasal cannula flow with or without supplemental oxygen will undergo a Room Air Challenge Test.
  2. Infants on RA alone will undergo a Hypoxia Challenge test.
  • Effects of Nasal Cannula Flow completed at 28, 32, 36, 40 and 52 week's GA. The flow will be increased through a nasal cannula. This test is to see how flow effects the breathing pattern.

A subset of infants will have an MRI between 37-40 weeks GA or before discharge, whichever comes first. The MRI will allow the doctors to look and see if there is any injury present in the brain that can be linked to an abnormal breathing pattern called periodic breathing.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • All infants born between 24 0/7 and 28 6/7 weeks GA admitted to the Neonatal Intensive Care Unit at St. Louis Children's Hospital will be considered for enrollment.

排除标准

  • Infants not likely to survive
  • Infant with significant heart disease
  • Infant with a significant congenital abnormalities of the central nervous system, nose, mouth lungs or ribs, or congenital diseases that affect lung growth
  • Physician refusal
  • Unlikely that the infant will be available for 52-week follow-up visit.

结局指标

主要结局

Respiratory phenotype based on physiologic testing

时间窗: 36 weeks post menstrual age

Categorization of subjects based on physiologic Challenge Tests into one of four respiratory phenotypes.

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 (1)

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