Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial
Not Applicable
Completed
- Conditions
- Anemia
- Registration Number
- NCT02103296
- Lead Sponsor
- Capt Alicia Prescott
- Brief Summary
The goal of this protocol is to establish a randomized clinical trial comparing the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute hemoglobin concentration and the percent change in hemoglobin concentration from baseline around 24 hours of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Birth weight less than 1200g or Gestational Age less than 30 weeks born at participating medical centers
Exclusion Criteria
- No specific exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent change in hemoglobin concentration from baseline 24 hours of life Absolute hemoglobin concentration 24 hours of life
- Secondary Outcome Measures
Name Time Method Hemoglobin concentration at one week of life one week Hemoglobin concentration at time of hospital discharge Approximately 10 - 16 weeks Number of blood donor exposures Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks. Use of Vasopressors Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks. Number/volume of packed red blood cell (pRBC) transfusions Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks Head Ultrasound Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age
Trial Locations
- Locations (6)
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Carl R. Darnall Army medical Center
🇺🇸Fort Hood, Texas, United States
San Antonio Military Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Portsmouth Naval Medical Center
🇺🇸Portsmouth, Virginia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Tripler Army Medical Center🇺🇸Honolulu, Hawaii, United States