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

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ClinicalTrials.gov Identifier: NCT01855347
Recruitment Status : Unknown
Verified August 2015 by Ricardo Castillo-Galvan, MD, Brigham and Women's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2013
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Ricardo Castillo-Galvan, MD, Brigham and Women's Hospital

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.


Condition or disease Intervention/treatment
Infant, Premature, Diseases Hypoxia Necrotizing Enterocolitis Device: Near Infrared Spectroscopy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Evaluation of Abdominal Tissue Oxygenation in Premature Infants Using Near Infrared Spectroscopy
Study Start Date : February 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
NIRS Monitoring with four channels regional areas of the preterm infant, such as: Submandibular, Periumbilical, Abdominal (Spleen region) and infant thigh.
Other Names:
  • Near Infrared Spectroscopy (NIRS)
  • NIRS Device
  • NIRS Monitor
  • INVOS 5100c
  • OxyAlert




Primary Outcome Measures :
  1. Abdominal Tissue Oxygenation in Preterm Infant [ Time Frame: 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.


Secondary Outcome Measures :
  1. Submandibular Tissue Oxygenation in Preterm Infant [ Time Frame: 5 days ]

    Submandibular Tissue Oxygenation will be assessed with the INVOS 5100c NIRS device in real time along with the abdominal oxygenation (Primary outcome) and we will follow it principally during feedings.

    It is also expressed in percentage.




Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855347


Contacts
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Contact: Ricardo Castillo-Galvan, MD 6177108995 rcastillo-galvan@partners.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital Newborn Medicine Department
Boston, Massachusetts, United States, 02215
Contact: Ricardo Castillo-Galvan, MD    617-710-8995    rcastillo-galvan@partners.org   
Sub-Investigator: Steven A Ringer, MD, PhD         
Principal Investigator: Ricardo Castillo-Galvan, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Ricardo Castillo-Galvan, MD Brigham and Women's Hospital
Study Chair: Maxwell Weinmann, MD Brigham and Women's Hospital
Study Director: Steven A Ringer, MD, PhD Brigham and Women's Hospital
Study Chair: Edward Kelly, MD Brigham and Women's Hospital

Additional Information:
Publications:

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Responsible Party: Ricardo Castillo-Galvan, MD, Newborn Medicine Department, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01855347    
Other Study ID Numbers: BWH-NICU/NIRS
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015
Keywords provided by Ricardo Castillo-Galvan, MD, Brigham and Women's Hospital:
Prematurity
Hypoxia
Necrotizing Enterocolitis
Near Infrared Spectroscopy
Abdominal tissue oxygenation
NICU
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Infant, Premature, Diseases
Hypoxia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Signs and Symptoms, Respiratory
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infant, Newborn, Diseases