Ignite Creation Date:
2024-05-06 @ 1:08 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01735578
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2012-11-22
Brief Title:
Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 075 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
The investigators hypothesize that significant anemia in VLBW infants will be associated with a baseline low cerebro-splanchnic oxygenation ratio CSOR 075 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
Detailed Description:
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 andor death despite aggressive treatment 1 The sequence of events leading to NEC appears to be multifactorial and complex 23 While epidemiologic studies have identified multiple factors that appear to increase an infants risk for the development of NEC other than prematurity no single predictive risk factor has been clearly delineated 45
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 075 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 075 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
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 075 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 075 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None