Evaluation of Abdominal Tissue Oxygenation in Premature Infants Using Near Infrared Spectroscopy

Summary

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.

Conditions

• Infant, Premature, Diseases
• Hypoxia
• Necrotizing Enterocolitis

Interventions

DEVICE

Near Infrared Spectroscopy

NIRS Monitoring with four channels regional areas of the preterm infant, such as: Submandibular, Periumbilical, Abdominal (Spleen region) and infant thigh.

Sponsors & Collaborators

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Ricardo Castillo-Galvan, MD · Brigham and Women's Hospital

• Maxwell Weinmann, MD · Brigham and Women's Hospital

• Steven A Ringer, MD, PhD · Brigham and Women's Hospital

• Edward Kelly, MD · Brigham and Women's Hospital

Eligibility

Max Age

3 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2016-06-30

Completion

2016-07-31

Countries

• United States

Study Locations