Phase 1
N=22
The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
Anemia of Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT00167388 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States — 2.02; 5.91; 7.66; 14.99 cm/sec — p=0.571
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- feed during blood transfusion (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States |
2.02; 5.91; 7.66; 14.99; 0.43; 3.61 | 0.571 |
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.
Eligibility Criteria
Inclusion Criteria
- Singleton infants born at 25-32 weeks gestation who are 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.
Data sourced from ClinicalTrials.gov (NCT00167388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.