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

NCT01855347 | Unknown

• 1 other identifier: BWH-NICU/NIRS
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prematurity; Hypoxia; Necrotizing Enterocolitis; Near Infrared Spectroscopy; Abdominal tissue oxygenation; NICU

Outcome Measures

Primary Outcomes (1)

• Abdominal Tissue Oxygenation in Preterm Infant

  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.

  5 days

Secondary Outcomes (1)

• Submandibular Tissue Oxygenation in Preterm Infant

  5 days

Study Arms (1)

Preterm infants

Preterm infants (32 to 36 weeks of postmenstrual age) will be evaluated with a Near infrared Spectroscopy monitor device.

Device: Near Infrared Spectroscopy

Interventions

Near Infrared Spectroscopy DEVICE

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

Also known as: Near Infrared Spectroscopy (NIRS), NIRS Device, NIRS Monitor, INVOS 5100c, OxyAlert

Preterm infants

Eligibility Criteria

• Age: Up to 3 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants (Premature Infants) from 32 to 36 weeks of post menstrual age hospitalized in the Neonatal Intensive Care Unit (NICU) at Brigham and Women's Hospital.

You may qualify if:

• 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

You may not qualify if:

• Congenital Heart Disease
• Non stable clinical condition
• Abdominal injuries (i.e. Omphalocele, Gastroschisis, Skin irritation) that impedes placement of the optodes

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital Newborn Medicine Department

Boston, Massachusetts, 02215, United States

Location

Related Publications (10)

• Wolfberg AJ, du Plessis AJ. Near-infrared spectroscopy in the fetus and neonate. Clin Perinatol. 2006 Sep;33(3):707-28, viii. doi: 10.1016/j.clp.2006.06.010.

  PMID: 16950321 BACKGROUND

• Pellicer A, Bravo Mdel C. Near-infrared spectroscopy: a methodology-focused review. Semin Fetal Neonatal Med. 2011 Feb;16(1):42-9. doi: 10.1016/j.siny.2010.05.003. Epub 2010 Jun 26.

  PMID: 20580625 BACKGROUND

• Weiss M, Schulz G, Fasnacht M, Balmer C, Fischer JE, Gerber AC, Bucher HU, Baenziger O. Transcutaneously measured near-infrared spectroscopic liver tissue oxygenation does not correlate with hepatic venous oxygenation in children. Can J Anaesth. 2002 Oct;49(8):824-9. doi: 10.1007/BF03017416.

  PMID: 12374712 BACKGROUND

• Wolf M, Greisen G. Advances in near-infrared spectroscopy to study the brain of the preterm and term neonate. Clin Perinatol. 2009 Dec;36(4):807-34, vi. doi: 10.1016/j.clp.2009.07.007.

  PMID: 19944837 BACKGROUND

• Patel J, Marks K, Roberts I, Azzopardi D, Edwards AD. Measurement of cerebral blood flow in newborn infants using near infrared spectroscopy with indocyanine green. Pediatr Res. 1998 Jan;43(1):34-9. doi: 10.1203/00006450-199801000-00006.

  PMID: 9432110 BACKGROUND

• Yoxall CW, Weindling AM, Dawani NH, Peart I. Measurement of cerebral venous oxyhemoglobin saturation in children by near-infrared spectroscopy and partial jugular venous occlusion. Pediatr Res. 1995 Sep;38(3):319-23. doi: 10.1203/00006450-199509000-00008.

  PMID: 7494653 BACKGROUND

• Dominguez KM, Moss RL. Necrotizing enterocolitis. Clin Perinatol. 2012 Jun;39(2):387-401. doi: 10.1016/j.clp.2012.04.011. Epub 2012 May 18.

  PMID: 22682387 BACKGROUND

• Dave V, Brion LP, Campbell DE, Scheiner M, Raab C, Nafday SM. Splanchnic tissue oxygenation, but not brain tissue oxygenation, increases after feeds in stable preterm neonates tolerating full bolus orogastric feeding. J Perinatol. 2009 Mar;29(3):213-8. doi: 10.1038/jp.2008.189. Epub 2008 Nov 20.

  PMID: 19020529 BACKGROUND

• Gay AN, Lazar DA, Stoll B, Naik-Mathuria B, Mushin OP, Rodriguez MA, Burrin DG, Olutoye OO. Near-infrared spectroscopy measurement of abdominal tissue oxygenation is a useful indicator of intestinal blood flow and necrotizing enterocolitis in premature piglets. J Pediatr Surg. 2011 Jun;46(6):1034-40. doi: 10.1016/j.jpedsurg.2011.03.025.

  PMID: 21683194 BACKGROUND

• Cortez J, Gupta M, Amaram A, Pizzino J, Sawhney M, Sood BG. Noninvasive evaluation of splanchnic tissue oxygenation using near-infrared spectroscopy in preterm neonates. J Matern Fetal Neonatal Med. 2011 Apr;24(4):574-82. doi: 10.3109/14767058.2010.511335. Epub 2010 Sep 9.

  PMID: 20828232 BACKGROUND

Related Links

• Premature infants (Medline)
• Necrotizing Enterocolitis (NIH)
• Preterm labor and birth (NIH)

MeSH Terms

Conditions

Infant, Premature, Diseases; Hypoxia; Enterocolitis, Necrotizing; Premature Birth

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ricardo Castillo-Galvan, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Maxwell Weinmann, MD

  Brigham and Women's Hospital

  STUDY CHAIR

• Steven A Ringer, MD, PhD

  Brigham and Women's Hospital

  STUDY DIRECTOR

• Edward Kelly, MD

  Brigham and Women's Hospital

  STUDY CHAIR

Central Study Contacts

Ricardo Castillo-Galvan, MD

CONTACT

6177108995; rcastillo-galvan@partners.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Newborn Medicine Department

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 16, 2013
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

US (1)