Necrotizing Enterocolitis Clinical Trial
Official title:
Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis
Verified date | December 2014 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 12 Weeks |
Eligibility |
Inclusion Criteria: 1. Premature infants of = 32 weeks gestational age 2. anemia (hematocrit of = 28 %) 3. full enteral feedings 4. stable clinical condition (no mechanical ventilation, no vasopressors, no sepsis) 5. Age = 12 weeks of life Exclusion Criteria: 1. Lack of parental consent 2. Multiple congenital anomalies 3. unstable clinical condition (mechanical ventilation, vasopressors, sepsis) 4. Previous medical or surgical NEC (defined as = Bell's Stage II disease) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation
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Neu J, Mshvildadze M, Mai V. A roadmap for understanding and preventing necrotizing enterocolitis. Curr Gastroenterol Rep. 2008 Oct;10(5):450-7. Review. — View 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. — View Citation
Yost CC. Neonatal necrotizing enterocolitis: diagnosis, management, and pathogenesis. J Infus Nurs. 2005 Mar-Apr;28(2):130-4. Review. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cerebro-splanchnic oxygenation ratio (CSOR) measurements | 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. | 24 hours | No |
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