Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02103296
Recruitment Status : Recruiting
First Posted : April 3, 2014
Last Update Posted : August 13, 2018
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

Tracking Information
First Submitted Date  ICMJE March 17, 2014
First Posted Date  ICMJE April 3, 2014
Last Update Posted Date August 13, 2018
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • Absolute hemoglobin concentration [ Time Frame: 24 hours of life ]
  • Percent change in hemoglobin concentration from baseline [ Time Frame: 24 hours of life ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02103296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • 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 ]
  • Number of blood donor exposures [ Time Frame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks. ]
  • Use of Vasopressors [ Time Frame: Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks. ]
  • Hemoglobin concentration at one week of life [ Time Frame: one week ]
  • Hemoglobin concentration at time of hospital discharge [ Time Frame: Approximately 10 - 16 weeks ]
  • Head Ultrasound [ Time Frame: Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial
Official Title  ICMJE Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight (VLBW) Preterm Neonates: A Multi-center Randomized Clinical Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Anemia
Intervention  ICMJE
  • Procedure: Drawing admission labs from cord blood
  • Procedure: Drawing admission labs from infant blood
Study Arms  ICMJE
  • Active Comparator: Infant Blood
    Control group. Admission labs to be drawn directly from the infant.
    Intervention: Procedure: Drawing admission labs from infant blood
  • Experimental: Cord Blood
    Admission labs to be drawn from the infant's cord blood
    Intervention: Procedure: Drawing admission labs from cord blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2014)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Day   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alicia C Prescott, DO 858-232-8459 alicia.c.prescott.mil@mail.mil
Contact: Thornton S Mu, MD 210-916-7047 thornton.s.mu.mil@mail.mil
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02103296
Other Study ID Numbers  ICMJE 393720-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Capt Alicia Prescott, San Antonio Military Medical Center
Study Sponsor  ICMJE Capt Alicia Prescott
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Thornton S Mu, MD San Antonio Military Medical Center
PRS Account San Antonio Military Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP