<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01735578</url>
  </required_header>
  <id_info>
    <org_study_id>58673</org_study_id>
    <nct_id>NCT01735578</nct_id>
  </id_info>
  <brief_title>Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis</brief_title>
  <official_title>Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in&#xD;
      the newborn intensive care unit and represents a significant cause of morbidity and mortality&#xD;
      in infants born prematurely. Among possible risk factors, a strong association between&#xD;
      elective RBC transfusions in premature infants with anemia and the subsequent development of&#xD;
      NEC has been consistently observed (6-11). However, a significant (and increasing) number of&#xD;
      VLBW infants with anemia are managed with erythropoiesis stimulating agents (such as Epo) and&#xD;
      iron and do not receive RBC transfusions during their hospital stay. The present study&#xD;
      proposes to study this particular group of VLBW infants that remain with low (&lt;28 %)&#xD;
      hematocrit while receiving full enteral feedings.&#xD;
&#xD;
      The investigators hypothesize that significant anemia in VLBW infants will be associated with&#xD;
      a baseline low cerebro-splanchnic oxygenation ratio (CSOR) (&lt;0.75) as measured by NIRS, and&#xD;
      that nasogastric feedings (NGF) in those particular patients will lead to further decreased&#xD;
      splanchnic oxygenation. The investigators further postulate that CSOR values will be&#xD;
      significantly lower among VLBW that develop NEC as compared to infants that do not.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in&#xD;
      the newborn intensive care unit and represents a significant cause of morbidity and mortality&#xD;
      in infants born prematurely. This disease complicates the management of approximately 6 - 10%&#xD;
      of very low birthweight (VLBW) infants and can result in significant feeding intolerance,&#xD;
      intestinal perforation and/or death despite aggressive treatment (1). The sequence of events&#xD;
      leading to NEC appears to be multifactorial and complex (2,3). While epidemiologic studies&#xD;
      have identified multiple factors that appear to increase an infant's risk for the development&#xD;
      of NEC, other than prematurity, no single predictive risk factor has been clearly delineated&#xD;
      (4,5).&#xD;
&#xD;
      Among possible risk factors, a strong association between elective RBC transfusions in&#xD;
      premature infants with anemia and the subsequent development of NEC has been consistently&#xD;
      observed (6-11). Possible explanations for transfusion-associated NEC have been proposed: 1)&#xD;
      the physiological impact of anemia that can initiate a cascade of events leading to&#xD;
      ischemic-hypoxemic mucosal gut injury predisposing to NEC (10); 2) increased splanchnic blood&#xD;
      flow following RBC transfusion leading to reperfusion injury of gut mucosa.&#xD;
&#xD;
      A significant (and increasing) number of VLBW infants with anemia are managed with&#xD;
      erythropoiesis stimulating agents (such as Epo) and iron and do not receive RBC transfusions&#xD;
      during their hospital stay. The present study proposes to study this particular group of VLBW&#xD;
      infants that remain with low (&lt;28 %) hematocrit while receiving full enteral feedings.&#xD;
&#xD;
      Near Infrared Spectroscopy (NIRS) is a non-invasive, FDA approved, bedside technology that&#xD;
      allows determination of regional oxygen saturations (rSO2) in tissues such as the gut&#xD;
      mesentery. Using NIRS, the oxygenation status of hemoglobin in tissues located 2-4 cm below&#xD;
      the skin can be determined and recorded continuously (12). For instance, Dave et al. used&#xD;
      NIRS to demonstrate that splanchnic rSO2, but not cerebral rSO2, increases after feeds in the&#xD;
      stable prematurely born infant tolerating full bolus orogastric feedings (13). Of importance,&#xD;
      the average hematocrit in this study group was 37% (±7) and therefore these babies had no&#xD;
      significant anemia.&#xD;
&#xD;
      While no normative values exist for mesenteric rSO2 in premature infants, recent studies have&#xD;
      explored NIRS use in determining gut hypoxia and ischemia (14). Abdominal NIRS was used to&#xD;
      detect alterations of intestinal rSO2 and perfusion in premature piglets that developed NEC&#xD;
      (15). In a prospective cohort study of 40 neonates with medical or surgical acute&#xD;
      intraabdominal pathology, a cerebro-splanchnic oxygenation ratio (CSOR) of less than 0.75&#xD;
      predicted gut ischemia with 90% sensitivity (16).&#xD;
&#xD;
      While these studies support a role for NIRS monitoring of mesenteric rSO2, it is not clear&#xD;
      whether 1) VLBW with significant anemia have perturbations in intestinal oxygenation and&#xD;
      perfusion, and 2) alterations in mesenteric rSO2 predict the development of NEC in VLBW&#xD;
      infants.&#xD;
&#xD;
      We hypothesize that significant anemia in VLBW infants will be associated with a baseline low&#xD;
      CSOR (&lt;0.75) as measured by NIRS, and that nasogastric feedings (NGF) in those particular&#xD;
      patients will lead to further decreased splanchnic oxygenation. We further postulate that&#xD;
      CSOR values will be significantly lower among VLBW that develop NEC as compared to infants&#xD;
      that do not.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cerebro-splanchnic oxygenation ratio (CSOR) measurements</measure>
    <time_frame>24 hours</time_frame>
    <description>Stable premature infants who are being fed but have hematocrits lower than or equal to 28 will be continuously monitored using near-infrared spectroscopy (NIRS) in the cerebral and mesenteric regions for 24 hours.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Anemia of Prematurity</condition>
  <condition>Necrotizing Enterocolitis</condition>
  <arm_group>
    <arm_group_label>Premature infants with anemia</arm_group_label>
    <description>Inpatient premature infants at the University of Utah Neonatal Intensive Care Unit (NICU) with Hct &lt; or = to 28 who are being fed and are stable.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Premature infants admitted to the University of Utah NICU with significant anemia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Premature infants of ≤ 32 weeks gestational age&#xD;
&#xD;
          2. anemia (hematocrit of ≤ 28 %)&#xD;
&#xD;
          3. full enteral feedings&#xD;
&#xD;
          4. stable clinical condition (no mechanical ventilation, no vasopressors, no sepsis)&#xD;
&#xD;
          5. Age ≤ 12 weeks of life&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lack of parental consent&#xD;
&#xD;
          2. Multiple congenital anomalies&#xD;
&#xD;
          3. unstable clinical condition (mechanical ventilation, vasopressors, sepsis)&#xD;
&#xD;
          4. Previous medical or surgical NEC (defined as ≥ Bell's Stage II disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariana Baserga, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Yost CC. Neonatal necrotizing enterocolitis: diagnosis, management, and pathogenesis. J Infus Nurs. 2005 Mar-Apr;28(2):130-4. doi: 10.1097/00129804-200503000-00007.</citation>
    <PMID>15785334</PMID>
  </reference>
  <reference>
    <citation>Frost BL, Jilling T, Caplan MS. The importance of pro-inflammatory signaling in neonatal necrotizing enterocolitis. Semin Perinatol. 2008 Apr;32(2):100-6. doi: 10.1053/j.semperi.2008.01.001.</citation>
    <PMID>18346533</PMID>
  </reference>
  <reference>
    <citation>Neu J, Mshvildadze M, Mai V. A roadmap for understanding and preventing necrotizing enterocolitis. Curr Gastroenterol Rep. 2008 Oct;10(5):450-7. doi: 10.1007/s11894-008-0084-x.</citation>
    <PMID>18799119</PMID>
  </reference>
  <reference>
    <citation>Lemons JA, Bauer CR, Oh W, Korones SB, Papile LA, Stoll BJ, Verter J, Temprosa M, Wright LL, Ehrenkranz RA, Fanaroff AA, Stark A, Carlo W, Tyson JE, Donovan EF, Shankaran S, Stevenson DK. Very low birth weight outcomes of the National Institute of Child health and human development neonatal research network, January 1995 through December 1996. NICHD Neonatal Research Network. Pediatrics. 2001 Jan;107(1):E1. doi: 10.1542/peds.107.1.e1.</citation>
    <PMID>11134465</PMID>
  </reference>
  <reference>
    <citation>Hunter CJ, Upperman JS, Ford HR, Camerini V. Understanding the susceptibility of the premature infant to necrotizing enterocolitis (NEC). Pediatr Res. 2008 Feb;63(2):117-23. doi: 10.1203/PDR.0b013e31815ed64c.</citation>
    <PMID>18091350</PMID>
  </reference>
  <reference>
    <citation>Christensen RD, Lambert DK, Henry E, Wiedmeier SE, Snow GL, Baer VL, Gerday E, Ilstrup S, Pysher TJ. Is &quot;transfusion-associated necrotizing enterocolitis&quot; an authentic pathogenic entity? Transfusion. 2010 May;50(5):1106-12. doi: 10.1111/j.1537-2995.2009.02542.x. Epub 2009 Dec 29.</citation>
    <PMID>20051059</PMID>
  </reference>
  <reference>
    <citation>Mally P, Golombek SG, Mishra R, Nigam S, Mohandas K, Depalhma H, LaGamma EF. Association of necrotizing enterocolitis with elective packed red blood cell transfusions in stable, growing, premature neonates. Am J Perinatol. 2006 Nov;23(8):451-8. doi: 10.1055/s-2006-951300. Epub 2006 Sep 28.</citation>
    <PMID>17009195</PMID>
  </reference>
  <reference>
    <citation>Josephson CD, Wesolowski A, Bao G, Sola-Visner MC, Dudell G, Castillejo MI, Shaz BH, Easley KA, Hillyer CD, Maheshwari A. Do red cell transfusions increase the risk of necrotizing enterocolitis in premature infants? J Pediatr. 2010 Dec;157(6):972-978.e1-3. doi: 10.1016/j.jpeds.2010.05.054. Epub 2010 Jul 21.</citation>
    <PMID>20650470</PMID>
  </reference>
  <reference>
    <citation>Blau J, Calo JM, Dozor D, Sutton M, Alpan G, La Gamma EF. Transfusion-related acute gut injury: necrotizing enterocolitis in very low birth weight neonates after packed red blood cell transfusion. J Pediatr. 2011 Mar;158(3):403-9. doi: 10.1016/j.jpeds.2010.09.015. Epub 2010 Nov 10.</citation>
    <PMID>21067771</PMID>
  </reference>
  <reference>
    <citation>Singh R, Visintainer PF, Frantz ID 3rd, Shah BL, Meyer KM, Favila SA, Thomas MS, Kent DM. Association of necrotizing enterocolitis with anemia and packed red blood cell transfusions in preterm infants. J Perinatol. 2011 Mar;31(3):176-82. doi: 10.1038/jp.2010.145. Epub 2011 Jan 27.</citation>
    <PMID>21273983</PMID>
  </reference>
  <reference>
    <citation>El-Dib M, Narang S, Lee E, Massaro AN, Aly H. Red blood cell transfusion, feeding and necrotizing enterocolitis in preterm infants. J Perinatol. 2011 Mar;31(3):183-7. doi: 10.1038/jp.2010.157. Epub 2011 Jan 20.</citation>
    <PMID>21252964</PMID>
  </reference>
  <reference>
    <citation>Baserga MC, Gregory GA, Sola A. Cerebrovascular response in small preterm infants during routine nursery gavage feedings. Biol Neonate. 2003;83(1):12-8. doi: 10.1159/000067011.</citation>
    <PMID>12566677</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19020529</PMID>
  </reference>
  <reference>
    <citation>Dani C, Pratesi S, Fontanelli G, Barp J, Bertini G. Blood transfusions increase cerebral, splanchnic, and renal oxygenation in anemic preterm infants. Transfusion. 2010 Jun;50(6):1220-6. doi: 10.1111/j.1537-2995.2009.02575.x. Epub 2010 Jan 22.</citation>
    <PMID>20113454</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21683194</PMID>
  </reference>
  <reference>
    <citation>Fortune PM, Wagstaff M, Petros AJ. Cerebro-splanchnic oxygenation ratio (CSOR) using near infrared spectroscopy may be able to predict splanchnic ischaemia in neonates. Intensive Care Med. 2001 Aug;27(8):1401-7. doi: 10.1007/s001340100994.</citation>
    <PMID>11511955</PMID>
  </reference>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>May 1, 2015</last_update_submitted>
  <last_update_submitted_qc>May 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>splanchnic oxygen saturations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterocolitis</mesh_term>
    <mesh_term>Enterocolitis, Necrotizing</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01735578
org study id: 58673
nct id: NCT01735578
lead sponsor: 
has dmc: No
Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in
      the newborn intensive care unit and represents a significant cause of morbidity and mortality
      in infants born prematurely. Among possible risk factors, a strong association between
      elective RBC transfusions in premature infants with anemia and the subsequent development of
      NEC has been consistently observed (6-11). However, a significant (and increasing) number of
      VLBW infants with anemia are managed with erythropoiesis stimulating agents (such as Epo) and
      iron and do not receive RBC transfusions during their hospital stay. The present study
      proposes to study this particular group of VLBW infants that remain with low (<28 %)
      hematocrit while receiving full enteral feedings.

      The investigators hypothesize that significant anemia in VLBW infants will be associated with
      a baseline low cerebro-splanchnic oxygenation ratio (CSOR) (<0.75) as measured by NIRS, and
      that nasogastric feedings (NGF) in those particular patients will lead to further decreased
      splanchnic oxygenation. The investigators further postulate that CSOR values will be
      significantly lower among VLBW that develop NEC as compared to infants that do not.
Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in
      the newborn intensive care unit and represents a significant cause of morbidity and mortality
      in infants born prematurely. This disease complicates the management of approximately 6 - 10%
      of very low birthweight (VLBW) infants and can result in significant feeding intolerance,
      intestinal perforation and/or death despite aggressive treatment (1). The sequence of events
      leading to NEC appears to be multifactorial and complex (2,3). While epidemiologic studies
      have identified multiple factors that appear to increase an infant's risk for the development
      of NEC, other than prematurity, no single predictive risk factor has been clearly delineated
      (4,5).

      Among possible risk factors, a strong association between elective RBC transfusions in
      premature infants with anemia and the subsequent development of NEC has been consistently
      observed (6-11). Possible explanations for transfusion-associated NEC have been proposed: 1)
      the physiological impact of anemia that can initiate a cascade of events leading to
      ischemic-hypoxemic mucosal gut injury predisposing to NEC (10); 2) increased splanchnic blood
      flow following RBC transfusion leading to reperfusion injury of gut mucosa.

      A significant (and increasing) number of VLBW infants with anemia are managed with
      erythropoiesis stimulating agents (such as Epo) and iron and do not receive RBC transfusions
      during their hospital stay. The present study proposes to study this particular group of VLBW
      infants that remain with low (<28 %) hematocrit while receiving full enteral feedings.

      Near Infrared Spectroscopy (NIRS) is a non-invasive, FDA approved, bedside technology that
      allows determination of regional oxygen saturations (rSO2) in tissues such as the gut
      mesentery. Using NIRS, the oxygenation status of hemoglobin in tissues located 2-4 cm below
      the skin can be determined and recorded continuously (12). For instance, Dave et al. used
      NIRS to demonstrate that splanchnic rSO2, but not cerebral rSO2, increases after feeds in the
      stable prematurely born infant tolerating full bolus orogastric feedings (13). Of importance,
      the average hematocrit in this study group was 37% (±7) and therefore these babies had no
      significant anemia.

      While no normative values exist for mesenteric rSO2 in premature infants, recent studies have
      explored NIRS use in determining gut hypoxia and ischemia (14). Abdominal NIRS was used to
      detect alterations of intestinal rSO2 and perfusion in premature piglets that developed NEC
      (15). In a prospective cohort study of 40 neonates with medical or surgical acute
      intraabdominal pathology, a cerebro-splanchnic oxygenation ratio (CSOR) of less than 0.75
      predicted gut ischemia with 90% sensitivity (16).

      While these studies support a role for NIRS monitoring of mesenteric rSO2, it is not clear
      whether 1) VLBW with significant anemia have perturbations in intestinal oxygenation and
      perfusion, and 2) alterations in mesenteric rSO2 predict the development of NEC in VLBW
      infants.

      We hypothesize that significant anemia in VLBW infants will be associated with a baseline low
      CSOR (<0.75) as measured by NIRS, and that nasogastric feedings (NGF) in those particular
      patients will lead to further decreased splanchnic oxygenation. We further postulate that
      CSOR values will be significantly lower among VLBW that develop NEC as compared to infants
      that do not.
observational model: Case-Only
time perspective: Prospective
measure: cerebro-splanchnic oxygenation ratio (CSOR) measurements
time frame: 24 hours
description: Stable premature infants who are being fed but have hematocrits lower than or equal to 28 will be continuously monitored using near-infrared spectroscopy (NIRS) in the cerebral and mesenteric regions for 24 hours.
arm group label: Premature infants with anemia
description: Inpatient premature infants at the University of Utah Neonatal Intensive Care Unit (NICU) with Hct < or = to 28 who are being fed and are stable.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Weeks
healthy volunteers: No
last name: Mariana Baserga, MD
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
citation: Yost CC. Neonatal necrotizing enterocolitis: diagnosis, management, and pathogenesis. J Infus Nurs. 2005 Mar-Apr;28(2):130-4. doi: 10.1097/00129804-200503000-00007.
PMID: 15785334
citation: Frost BL, Jilling T, Caplan MS. The importance of pro-inflammatory signaling in neonatal necrotizing enterocolitis. Semin Perinatol. 2008 Apr;32(2):100-6. doi: 10.1053/j.semperi.2008.01.001.
PMID: 18346533
citation: Neu J, Mshvildadze M, Mai V. A roadmap for understanding and preventing necrotizing enterocolitis. Curr Gastroenterol Rep. 2008 Oct;10(5):450-7. doi: 10.1007/s11894-008-0084-x.
PMID: 18799119
citation: Lemons JA, Bauer CR, Oh W, Korones SB, Papile LA, Stoll BJ, Verter J, Temprosa M, Wright LL, Ehrenkranz RA, Fanaroff AA, Stark A, Carlo W, Tyson JE, Donovan EF, Shankaran S, Stevenson DK. Very low birth weight outcomes of the National Institute of Child health and human development neonatal research network, January 1995 through December 1996. NICHD Neonatal Research Network. Pediatrics. 2001 Jan;107(1):E1. doi: 10.1542/peds.107.1.e1.
PMID: 11134465
citation: Hunter CJ, Upperman JS, Ford HR, Camerini V. Understanding the susceptibility of the premature infant to necrotizing enterocolitis (NEC). Pediatr Res. 2008 Feb;63(2):117-23. doi: 10.1203/PDR.0b013e31815ed64c.
PMID: 18091350
citation: Christensen RD, Lambert DK, Henry E, Wiedmeier SE, Snow GL, Baer VL, Gerday E, Ilstrup S, Pysher TJ. Is "transfusion-associated necrotizing enterocolitis" an authentic pathogenic entity? Transfusion. 2010 May;50(5):1106-12. doi: 10.1111/j.1537-2995.2009.02542.x. Epub 2009 Dec 29.
PMID: 20051059
citation: Mally P, Golombek SG, Mishra R, Nigam S, Mohandas K, Depalhma H, LaGamma EF. Association of necrotizing enterocolitis with elective packed red blood cell transfusions in stable, growing, premature neonates. Am J Perinatol. 2006 Nov;23(8):451-8. doi: 10.1055/s-2006-951300. Epub 2006 Sep 28.
PMID: 17009195
citation: Josephson CD, Wesolowski A, Bao G, Sola-Visner MC, Dudell G, Castillejo MI, Shaz BH, Easley KA, Hillyer CD, Maheshwari A. Do red cell transfusions increase the risk of necrotizing enterocolitis in premature infants? J Pediatr. 2010 Dec;157(6):972-978.e1-3. doi: 10.1016/j.jpeds.2010.05.054. Epub 2010 Jul 21.
PMID: 20650470
citation: Blau J, Calo JM, Dozor D, Sutton M, Alpan G, La Gamma EF. Transfusion-related acute gut injury: necrotizing enterocolitis in very low birth weight neonates after packed red blood cell transfusion. J Pediatr. 2011 Mar;158(3):403-9. doi: 10.1016/j.jpeds.2010.09.015. Epub 2010 Nov 10.
PMID: 21067771
citation: Singh R, Visintainer PF, Frantz ID 3rd, Shah BL, Meyer KM, Favila SA, Thomas MS, Kent DM. Association of necrotizing enterocolitis with anemia and packed red blood cell transfusions in preterm infants. J Perinatol. 2011 Mar;31(3):176-82. doi: 10.1038/jp.2010.145. Epub 2011 Jan 27.
PMID: 21273983
citation: El-Dib M, Narang S, Lee E, Massaro AN, Aly H. Red blood cell transfusion, feeding and necrotizing enterocolitis in preterm infants. J Perinatol. 2011 Mar;31(3):183-7. doi: 10.1038/jp.2010.157. Epub 2011 Jan 20.
PMID: 21252964
citation: Baserga MC, Gregory GA, Sola A. Cerebrovascular response in small preterm infants during routine nursery gavage feedings. Biol Neonate. 2003;83(1):12-8. doi: 10.1159/000067011.
PMID: 12566677
citation: 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
citation: Dani C, Pratesi S, Fontanelli G, Barp J, Bertini G. Blood transfusions increase cerebral, splanchnic, and renal oxygenation in anemic preterm infants. Transfusion. 2010 Jun;50(6):1220-6. doi: 10.1111/j.1537-2995.2009.02575.x. Epub 2010 Jan 22.
PMID: 20113454
citation: 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
citation: Fortune PM, Wagstaff M, Petros AJ. Cerebro-splanchnic oxygenation ratio (CSOR) using near infrared spectroscopy may be able to predict splanchnic ischaemia in neonates. Intensive Care Med. 2001 Aug;27(8):1401-7. doi: 10.1007/s001340100994.
PMID: 11511955
responsible party type: Sponsor
mesh term: Enterocolitis
mesh term: Enterocolitis, Necrotizing