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Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02103296
Recruitment Status : Active, not recruiting
First Posted : April 3, 2014
Last Update Posted : October 23, 2020
Sponsor:
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
Information provided by (Responsible Party):
Capt Alicia Prescott, San Antonio Military Medical Center

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.

Condition or disease Intervention/treatment Phase
Anemia Procedure: Drawing admission labs from cord blood Procedure: Drawing admission labs from infant blood Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : February 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
Active Comparator: Infant Blood
Control group. Admission labs to be drawn directly from the infant.
Procedure: Drawing admission labs from infant blood
Experimental: Cord Blood
Admission labs to be drawn from the infant's cord blood
Procedure: Drawing admission labs from cord blood



Primary Outcome Measures :
  1. Absolute hemoglobin concentration [ Time Frame: 24 hours of life ]
  2. Percent change in hemoglobin concentration from baseline [ Time Frame: 24 hours of life ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of blood donor exposures [ Time Frame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks. ]
  3. Use of Vasopressors [ Time Frame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks. ]
  4. Hemoglobin concentration at one week of life [ Time Frame: one week ]
  5. Hemoglobin concentration at time of hospital discharge [ Time Frame: Approximately 10 - 16 weeks ]
  6. Head Ultrasound [ Time Frame: Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103296


Locations
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United States, Hawaii
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Texas
Carl R. Darnall Army medical Center
Fort Hood, Texas, United States, 78109
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78234
United States, Virginia
Portsmouth Naval Medical Center
Portsmouth, Virginia, United States, 23708
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Capt Alicia Prescott
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
Investigators
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Principal Investigator: Thornton S Mu, MD San Antonio Military Medical Center
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Responsible Party: Capt Alicia Prescott, Associate Investogator, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT02103296    
Other Study ID Numbers: 393720-1
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Birth Weight
Body Weight