Packed Red Blood Cell Transfusion and Intestinal Blood Flow in Preterm Neonates

NCT01628133 | Completed DMC

• 1 other identifier: '20969
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether packed red blood cell (PRBC) transfusion affects intestinal blood flow of premature infants during feedings and if so, whether return of normal intestinal blood flow pattern occurs within 48 hours of blood transfusion. Abnormal intestinal responses to the feedings (insufficient postprandial blood flow increase in order to digest given feeding volume or overall decrease of intestinal blood flow) may predispose infants to feeding intolerance and to serious intestinal disease called necrotizing enterocolitis (NEC). Patent ductus arteriosus (PDA) is a relatively common heart condition found in young preterm infants that can lead to decreased blood flow in different organs, including intestines. Thus, the determination of the presence or absence of PDA is an important part of the study, since it can be a relevant confounding variable. In this study, the investigators will assess intestinal blood flow by using sonogram to measure velocity through the superior mesenteric artery (SMA), the artery supplying most of the intestine, both pre- and 45 minutes post feeding. The investigators will also use echocardiogram to determine the presence or absence of PDA. Each set of measurements will be done immediately before and after the transfusion, and again 24 and 48 hours after the transfusion. Specific Hypothesis: The investigators hypothesize that infants will have attenuated postprandial blood flow velocities in immediate posttransfusion state when compared to the pretransfusion values. The investigators further hypothesize that normal, pretransfusion postprandial blood flow velocities will be achieved 48 hrs after the blood transfusion.

Conditions

Intestinal Blood Flow

Keywords

Transfusion; Neonate; Infant, Very Low Birth Weight; Patent Ductus Arteriosus; Packed Red Blood Cell

Outcome Measures

Primary Outcomes (1)

• Assessing intestinal blood flow by comparing superior mesenteric artery velocities in preterm neonates before and after packed red blood cell transfusion using sonogram.

  Prospective investigation of pre- and post-prandial (45 minutes after feeding completion) SMA BVF in preterm neonates before and after blood transfusion. The pretransfusion SMA BFV measurements (pre- and post-prandial) are done during the last feeding before the transfusion; the postransfusion SMA BFV (pre- and post-prandial) measurements are done during the first feeding immediately following the blood transfusion and again during the feedings 24 and 48 hrs after the transfusion (Total of 8 SMA BFV assessments).

  Measurements are obtained both before and 45 minutes after feeding prior to transfusion; again before and after feeding after transfusion and again at 24 and 48 hours after the transfusion.

Secondary Outcomes (1)

• To determine whether packed red blood cell transfusion affects patent ductus arteriosus status of the subjects using Echocardiogram to determine the presence or absence of PDA.

  Each set of measurements will be done immediately before and after the transfusion, and again 24 and 48 hours after the transfusion.

Study Arms (1)

blood transfusion group

Procedure: ultrasound

Interventions

ultrasound PROCEDURE

sonographic evaluation of intestinal blood flow

blood transfusion group

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm neonates (≤1500 grams of birth weight) of singleton and multiple births who are admitted to the NICU at Cardinal Glennon Children's Hospital and who are tolerating ≥ 20 ml/kg/day of feeding volume run over 30 minutes or less; both males and females of all ethnic groups. Very Low Birth Weight (VLBW) neonates will be studied since morbidities such as transfusion related acute gastrointestinal injury and/or necrotizing enterocolitis, PDA and feeding intolerance most frequently occur in this group. Because the need to ensure parental comprehension prior to consent documentation, parents who, in the judgement of the attending physician and/or research team members, do not have an adequate command of the English language will not be invited to participate in the study.

You may qualify if:

• birth weight ≤ 1500 gm
• singleton and multiple gestation
• small and appropriate birth weight for gestational age
• tolerance of ≥ 20 ml/kg/day of feeding volumes over 30 minutes or less
• at least 14 days of age and ≤ 35 6/7 weeks corrected gestational age at time of transfusion.
• Expected age range of 0-3 months is based on expected age of extremely low birth weight infants at limit (35 6/7 weeks) of corrected gestational age.
• Only those infants who receive transfusion at \< or equal to 35 weeks will undergo the PDA/SMA and BFV procedures and have data included in analysis.

You may not qualify if:

• major congenital or chromosomal anomalies
• presence of congenital heart disease (minus patent ductus arteriosus
• presence of shock
• presence of vasopressor use
• presence of severe lung disease
• concurrent treatment with antibiotics for sepsis
• history of NEC Bell stage 2 or greater
• Infants experiencing changes in vital signs or oxygen level drop needing intervention (such as oxygen increase or stimulation) will have studies discontinued and will be excluded from further analysis.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Cardinal Glennon Children's Hospital / Saint Louis University

St Louis, Missouri, 63104, United States

Location

Related Publications (13)

• Stoll BJ. Epidemiology of necrotizing enterocolitis. Clin Perinatol. 1994 Jun;21(2):205-18. doi: 10.1016/S0095-5108(18)30341-5.

  PMID: 8070222 BACKGROUND

• Luig M, Lui K; NSW & ACT NICUS Group. Epidemiology of necrotizing enterocolitis--Part II: Risks and susceptibility of premature infants during the surfactant era: a regional study. J Paediatr Child Health. 2005 Apr;41(4):174-9. doi: 10.1111/j.1440-1754.2005.00583.x.

  PMID: 15813870 BACKGROUND

• Holman RC, Stoll BJ, Clarke MJ, Glass RI. The epidemiology of necrotizing enterocolitis infant mortality in the United States. Am J Public Health. 1997 Dec;87(12):2026-31. doi: 10.2105/ajph.87.12.2026.

  PMID: 9431297 BACKGROUND

• La Gamma EF, Browne LE. Feeding practices for infants weighing less than 1500 G at birth and the pathogenesis of necrotizing enterocolitis. Clin Perinatol. 1994 Jun;21(2):271-306.

  PMID: 8070227 BACKGROUND

• Uauy RD, Fanaroff AA, Korones SB, Phillips EA, Phillips JB, Wright LL. Necrotizing enterocolitis in very low birth weight infants: biodemographic and clinical correlates. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1991 Oct;119(4):630-8. doi: 10.1016/s0022-3476(05)82418-7.

  PMID: 1919897 BACKGROUND

• Obladen M. Necrotizing enterocolitis--150 years of fruitless search for the cause. Neonatology. 2009;96(4):203-10. doi: 10.1159/000215590. Epub 2009 Apr 29.

  PMID: 19407465 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Paul DA, Mackley A, Novitsky A, Zhao Y, Brooks A, Locke RG. Increased odds of necrotizing enterocolitis after transfusion of red blood cells in premature infants. Pediatrics. 2011 Apr;127(4):635-41. doi: 10.1542/peds.2010-3178. Epub 2011 Mar 14.

  PMID: 21402638 BACKGROUND

• 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 BACKGROUND

• Agwu JC, Narchi H. In a preterm infant, does blood transfusion increase the risk of necrotizing enterocolitis? Arch Dis Child. 2005 Jan;90(1):102-3. doi: 10.1136/adc.2004.051532. No abstract available.

  PMID: 15613530 BACKGROUND

• Krimmel GA, Baker R, Yanowitz TD. Blood transfusion alters the superior mesenteric artery blood flow velocity response to feeding in premature infants. Am J Perinatol. 2009 Feb;26(2):99-105. doi: 10.1055/s-0028-1090595. Epub 2008 Nov 19.

  PMID: 19021097 BACKGROUND

• Simmonds A, LaGamma EF. Addressing the

  BACKGROUND

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Thomas Havranek, MD

  Saint Louis University, Cardinal Glennon Children's Hospital

  STUDY DIRECTOR

• Aaron Pitzele, MD

  Saint Louis University, Cardinal Glennon Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associte Professor of Pediatrics

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 26, 2012
• Study Start: December 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: January 1, 2014
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

US (1)