The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants (NCT00167388) | Clinical Trial Compass
CompletedPhase 1
The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
United States22 participantsStarted 2005-09
Plain-language summary
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.
Who can participate
Age range25 Weeks – 38 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
✕
What they're measuring
1
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States