The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants

Completed · Phase 1

Conditions studied: Anemia of Prematurity

In brief

The purpose of the study is to see if a blood transfusion changes how fast blood flows to the intestines of a premature baby. Blood flow is measured by an ultrasound test. The investigators also look to see if the blood flow to the intestines depends on whether the baby feeds or doesn't feed during the blood transfusion.

Key facts

Study ID

NCT00167388

Run by

University of Pittsburgh

People needed

22

Starts

2005-09-01

Expected to finish

2006-11-01

Last updated by the study team

2017-07-21

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Singleton infants born at 25-32 weeks gestation who are < 38 weeks post-conceptual age at enrollment
• First infant of twin gestation born at 25-32 weeks gestation who requires a blood transfusion; if both infants require transfusion on the same day the larger infant will be enrolled.
• Receiving bolus enteral feeds [PO (bottle) and/or PE (feeding tube)] of at least 60 cc/kg/day
• A planned packed red blood cell transfusion, as per the clinical team, for anemia
• Infant is very likely to require a blood transfusion according to the attending neonatologist.

You may not qualify if…

• Known congenital anomalies of the heart, brain, kidneys or intestine
• Chromosomal abnormality
• Intrauterine growth restriction at < 3% for weight at birth since this has been shown to alter mesenteric BFV and the post-prandial hyperemia
• Twin to twin transfusion sequence
• Higher order multiples
• Patent ductus arteriosus known to be present or currently being treated
• History of definite necrotizing enterocolitis Bell Stage 2 or greater
• Concurrent treatments with antibiotics or steroids
• Feeding intolerance, defined as gastric aspirate > 30% of feed volume on 3 sequential feeds
• Concurrent enrollment in another randomized trial
• Infants discharged or transferred to another facility without having received a PRBC transfusion will be excluded post-hoc.

Where it is running

• Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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