Evaluation of Abdominal Tissue Oxygenation in Premature Infants Using Near Infrared Spectroscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Abdominal Tissue Oxygenation in Preterm Infant
研究概览
简要总结
There is an increasing incidence of Necrotizing Enterocolitis (NEC) affecting the premature infant population, principally those with associated risk like extreme prematurity, extreme low birth weight, associated co-morbidities (Congenital heart disease, perinatal asphyxia) and those born in hospitals with limited resources for optimal neonatal care.
Near Infrared Spectroscopy (NIRS), has been used in premature infants to evaluate changes in cerebral perfusion and oxygenation. (1) It provides real time insight into the oxygen delivery.(3) In the premature patient population, many neurologic injuries occur as a result of prenatal (pre-existing) and/or postnatal disturbance on oxygen delivery. NIRS has been focused in cerebral monitoring. Light easily penetrates through neonatal bone and skin tissue, and allows to monitor the subjacent oxygen content. Early studies were performed to validate NIRS measurements and have established normative data.(4-6) The non-invasive method of monitoring cerebral hemodynamics and oxygenation has revolutionized the intensive care units in patients at risk for neurological injuries. This method has been successfully validated to monitor neonatal cerebral oxygenation in different clinical settings and study protocols. (7) NIRS provides non-invasive, continuous information on tissue perfusion and oxygen dynamics.
One of the biggest challenges of NEC spectrum diseases is in the making of early diagnosis. It is important to monitor not just cerebral perfusion but also the intestinal oxygenation.(8,9) Previous studies with NIRS have demonstrated that premature infants change their cerebral - splanchnic oxygenation ratios during feedings.(10) Guy et al. performed NIRS in premature piglets to demonstrate association of perfusion change with NEC spectrum(11,12); these studies suggest evidence that NIRS could be a useful diagnostic tool in the premature infant population trough abdominal NIRS (a-NIRS) measurement capable of detecting alterations in intestinal oxygenation and perfusion.
In summary, a-NIRS could be use in the premature infant population to define reference values, especially in patients at risk, which would then facilitate the early diagnosis of NEC spectrum diseases.
详细描述
We will include, 10 premature infants from 32 to 36 weeks of post menstrual age, within the first week of life, that are clinically stable without diagnosis of Congenital Heart Disease, Necrotizing Enterocolitis, Sepsis or having been transfused less than three days before the evaluation. Infants with abdominal injuries, omphalocele, gastroschisis and abdominal skin irritation that does not permit the application of the probes will also be excluded.
10 premature infants from 32 to 36 weeks of post menstrual age will be included, after their first week of life, clinically stable status, and without diagnosis of Congenital Heart Disease, Necrotizing Enterocolitis, Sepsis or blood transfused less than three days before the moment of the evaluation. Infants with abdominal injuries, Omphalocele, Gastroschisis, skin irritation also will be excluded. NIRS device will record and monitor the Regional Oxygen Saturation (rSO2) in the infant during one week.
The evaluation will take place ar the Neonatal Intensive Care Unit (NICU), 6th floor at the Mary Horrigan Connors Center for Women's Health, Brigham and Women's Hospital. (http://www.brighamandwomens.org/newbornmedicine)
We will use a Near infrared spectroscopy (NIRS) device the INVOS 5100c (Covidien), catalogued under de Investigational Device Exemption (IDE) as 'non-significant risk device' (21 CFR 812.2) in order to perform monitoring as well as record-keeping with non-risk for the subject. No need Food and Drug Administration (FDA) clearance.
The application of the INVOS 5100c (Covidien) sensor optodes will be positioned in four locations (four channels), these will be in the lower abdomen, taking place bellow the umbilicus, with care, flush against the skin; in the submandibular region; upper left abdomen as well as in the thigh either left or right.
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
- — 至 3 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infant (32 to 36 weeks of postmenstrual age)
- •Neonatal intensive care unit (NICU) patient
- •Stable clinical condition (i.e. Vital signs, Hemodynamics)
- •Age less than 6 weeks of life
排除标准
- •Congenital Heart Disease
- •Necrotizing enterocolitis prior to inclusion
- •Non stable clinical condition
- •Blood transfused less than three days prior to inclusion
- •Abdominal injuries (i.e. Omphalocele, Gastroschisis, Skin irritation) that impedes placement of the optodes
结局指标
主要结局
Abdominal Tissue Oxygenation in Preterm Infant
时间窗: 5 days
Abdominal Tissue Oxygenation will be assessed with the Near Infrared Spectroscopy (NIRS) device, the INVOS 5100c with a time frame of one week in each of the participants, this device will monitor the oxygen tissue status in percentage unit. This outcome measure will be compare during this time frame and the underlying clinical status of the neonate. We then will look for an association between low percentages in the outcome measure and clinical evidences of Necrotizing Enterocolitis.
次要结局
- Submandibular Tissue Oxygenation in Preterm Infant(5 days)
研究者
Ricardo Castillo-Galvan, MD
Newborn Medicine Department
Brigham and Women's Hospital