Status:
COMPLETED
The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Irene McLeneham Young Investigator Award through Magee Womens Research Institute
Conditions:
Anemia of Prematurity
Eligibility:
All Genders
25-38 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Currently a disparity exists among the NICU staff at Magee-Womens Hospital regarding whether premature infants should be fed during a blood transfusion. The effects of a blood transfusion on superior ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00167388
Start Date
September 1 2005
End Date
November 1 2006
Last Update
July 21 2017
Active Locations (1)
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1
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213