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

August 18, 2021 updated by: Capt Alicia Prescott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
    • Texas
      • Fort Hood, Texas, United States, 78109
        • Carl R. Darnall Army Medical Center
      • Fort Sam Houston, Texas, United States, 78234
        • San Antonio Military Medical Center
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Portsmouth Naval Medical Center
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute hemoglobin concentration
Time Frame: 24 hours of life
24 hours of life
Percent change in hemoglobin concentration from baseline
Time Frame: 24 hours of life
24 hours of life

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
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.
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
one week
Hemoglobin concentration at time of hospital discharge
Time Frame: Approximately 10 - 16 weeks
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
Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capt Alicia Prescott

Collaborators

Walter Reed National Military Medical Center
United States Naval Medical Center, Portsmouth
Madigan Army Medical Center
C.R.Darnall Army Medical Center
Tripler Army Medical Center

Investigators

  • Principal Investigator: Thornton S Mu, MD, San Antonio Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

July 25, 2021

Study Completion (Actual)

July 25, 2021

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 31, 2014

First Posted (Estimate)

April 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 393720-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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