Clinical Trials Logo

Clinical Trial 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) (<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.


Clinical Trial 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 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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01735578
Study type Observational
Source University of Utah
Contact
Status Completed
Phase N/A
Start date October 2012
Completion date April 2015

See also
  Status Clinical Trial Phase
Recruiting NCT05544097 - Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis N/A
Recruiting NCT03210831 - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Recruiting NCT02552706 - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis N/A
Completed NCT02400697 - Placental Transfusion Project for Preterm Infants N/A
Completed NCT01751477 - Infloran® for Prevention of Necrotizing Enterocolitis N/A
Terminated NCT01156480 - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Recruiting NCT01441739 - Intestinal Failure in Necrotising Enterocolitis N/A
Recruiting NCT03869827 - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Recruiting NCT04074824 - A Genome-Wide Association Study for Neonatal Diseases
Terminated NCT03320785 - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting NCT03554278 - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting NCT04541771 - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Phase 2
Not yet recruiting NCT03700957 - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT01745510 - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates Phase 1/Phase 2
Unknown status NCT01807858 - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants N/A
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1