Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis

Completed

Conditions studied: Anemia of Prematurity, Necrotizing Enterocolitis

In brief

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.

Key facts

Study ID

NCT01735578

Run by

University of Utah

People needed

52

Starts

2012-10-01

Expected to finish

2015-04-01

Last updated by the study team

2015-05-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Premature infants of ≤ 32 weeks gestational age
• anemia (hematocrit of ≤ 28 %)
• full enteral feedings
• stable clinical condition (no mechanical ventilation, no vasopressors, no sepsis)
• Age ≤ 12 weeks of life

You may not qualify if…

• Lack of parental consent
• Multiple congenital anomalies
• unstable clinical condition (mechanical ventilation, vasopressors, sepsis)
• Previous medical or surgical NEC (defined as ≥ Bell's Stage II disease)

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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