Back to resultsUmbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial
Primary Purpose
Anemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drawing admission labs from cord blood
Drawing admission labs from infant blood
Sponsored by
About this trial
This is an interventional prevention trial for Anemia
Eligibility Criteria
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
Sites / Locations
- Tripler Army Medical Center
- Walter Reed National Military Medical Center
- Carl R. Darnall Army medical Center
- San Antonio Military Medical Center
- Portsmouth Naval Medical Center
- Madigan Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Infant Blood
Cord Blood
Arm Description
Control group. Admission labs to be drawn directly from the infant.
Admission labs to be drawn from the infant's cord blood
Outcomes
Primary Outcome Measures
Absolute hemoglobin concentration
Percent change in hemoglobin concentration from baseline
Secondary Outcome Measures
Number/volume of packed red blood cell (pRBC) transfusions
Number of blood donor exposures
Use of Vasopressors
Hemoglobin concentration at one week of life
Hemoglobin concentration at time of hospital discharge
Head Ultrasound
Full Information
NCT ID
NCT02103296
First Posted
March 17, 2014
Last Updated
August 18, 2021
Sponsor
Capt Alicia Prescott
Collaborators
C.R.Darnall Army Medical Center, Walter Reed National Military Medical Center, United States Naval Medical Center, Portsmouth, Madigan Army Medical Center, Tripler Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02103296
Brief Title
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial
Official Title
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight (VLBW) Preterm Neonates: A Multi-center Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 25, 2021 (Actual)
Study Completion Date
July 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Capt Alicia Prescott
Collaborators
C.R.Darnall Army Medical Center, Walter Reed National Military Medical Center, United States Naval Medical Center, Portsmouth, Madigan Army Medical Center, Tripler Army Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infant Blood
Arm Type
Active Comparator
Arm Description
Control group. Admission labs to be drawn directly from the infant.
Arm Title
Cord Blood
Arm Type
Experimental
Arm Description
Admission labs to be drawn from the infant's cord blood
Intervention Type
Procedure
Intervention Name(s)
Drawing admission labs from cord blood
Intervention Type
Procedure
Intervention Name(s)
Drawing admission labs from infant blood
Primary Outcome Measure Information:
Title
Absolute hemoglobin concentration
Time Frame
24 hours of life
Title
Percent change in hemoglobin concentration from baseline
Time Frame
24 hours of life
Secondary Outcome Measure Information:
Title
Number/volume of packed red blood cell (pRBC) transfusions
Time Frame
Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks
Title
Number of blood donor exposures
Time Frame
Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Title
Use of Vasopressors
Time Frame
Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Title
Hemoglobin concentration at one week of life
Time Frame
one week
Title
Hemoglobin concentration at time of hospital discharge
Time Frame
Approximately 10 - 16 weeks
Title
Head Ultrasound
Time Frame
Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thornton S Mu, MD
Organizational Affiliation
San Antonio Military Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Carl R. Darnall Army medical Center
City
Fort Hood
State/Province
Texas
ZIP/Postal Code
78109
Country
United States
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Portsmouth Naval Medical Center
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34407547
Citation
Mu TS, Prescott AC, Haischer-Rollo GD, Aden JK, Shapiro JB. Umbilical Cord Blood Use for Admission Blood Tests of VLBW Preterm Neonates: A Randomized Control Trial. Am J Perinatol. 2023 Jul;40(10):1119-1125. doi: 10.1055/s-0041-1733781. Epub 2021 Aug 18.
Results Reference
derived
Learn more about this trial
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial
We'll reach out to this number within 24 hrs