Packed Red Blood Cell Transfusion and Intestinal Blood Flow in Preterm Neonates
Completed
Conditions studied: Intestinal Blood Flow
In brief
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.
Key facts
- Study ID
- NCT01628133
- Run by
- St. Louis University
- People needed
- 25
- Starts
- 2011-12-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2014-06-20
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Cardinal Glennon Children's Hospital / Saint Louis University — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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