跳至主要内容
临床试验/NCT03723889
NCT03723889已完成不适用

Effect of Patent Ductus Arteriosus on Splanchnic Oxygenation at Enteral Feeding Introduction in Preterm Infants

IRCCS Azienda Ospedaliero-Universitaria di Bologna0 个研究点目标入组 50 人开始时间: 2013年11月1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
50
主要终点
Between-group SCOR difference after enteral feeding introduction

研究概览

简要总结

Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may results in pulmonary hyperperfusion and systemic hypoperfusion. As consequence of splanchnic hypoperfusion ensuing from left-to-right PDA shunting, a possible association between hemodynamically significant PDA and adverse gastrointestinal outcomes has been reported.

An impaired blood flow velocity in superior mesenteric artery, evaluated by Doppler ultrasound, has been previously reported before and after feeds in infants with large PDA, whereas evidence on PDA effect on splanchnic tissue oxygenation, measured by Near Infrared Spectroscopy, is scarce and controversial.

This study aims to evaluate whether splanchnic oxygenation patterns in response to enteral feeding introduction in preterm infants may be affected by PDA status.

详细描述

Patent ductus arteriosus (PDA) is a common condition among preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, possibly resulting in pulmonary blood flow overload and systemic hypoperfusion. A possible association with hemodynamically significant PDA and the occurrence of adverse gastrointestinal outcomes has been reported as a possible consequence of mesenteric hypoperfusion ensuing from left-to-right shunt through the PDA.

Previous attempts to assess by Doppler ultrasound the effect of PDA on blood flow velocity in superior mesenteric artery (SMA BFV) showed a decreased SMA BFV before and after feedings and attenuated postprandial increases in infants with large PDA. Near-infrared spectroscopy (NIRS) provides a non-invasive measurement of regional tissue oxygen saturation and has been previously applied in neonatal settings for the monitoring of cerebral (CrSO2) or splanchnic (SrSO2) oxygen saturation. Current evidence on the effect of PDA on SrSO2 is scarce and controversial; moreover, a possible effect of PDA on SrSO2 patterns in response to enteral feeding introduction has not been evaluated yet.

This study aims to evaluate whether SrSO2 patterns in response to enteral feeding introduction in preterm infants may be affected by the ductal status. The development of intestinal complications in relation to PDA are also evaluated.

Preterm infants <32 weeks admitted to the Neonatal Intensive Care Unit (NICU) are consecutively enrolled in the study if younger than 3 days and if no enteral feeding has been administered prior to the enrollment.

Written, informed consent to participate in the study is obtained from the parents/legal guardians of each infant before introducing enteral feeding.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Day 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age <32 weeks
  • no enteral feeding prior to the enrollment

排除标准

  • major congenital malformations, including congenital heart disease

结局指标

主要结局

Between-group SCOR difference after enteral feeding introduction

时间窗: 3.5 hours

Comparison of SCOR values in response to the first enteral feed in infants with evidence of PDA and infants with no evidence of PDA

Between-group SrSO2 difference after enteral feeding introduction

时间窗: 3.5 hours

Comparison of SrSO2 values in response to the first enteral feed in infants with evidence of PDA and infants with no evidence of PDA

次要结局

未报告次要终点

研究者

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

Luigi Corvaglia

Associate Professor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

相似试验

Patent Ductus Arteriosus and Splanchnic Oxygenation... | 临床试验