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NCT Number: NCT02103296

Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight 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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tripler Army Medical Center, Honolulu, Hawaii, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drawing admission labs from cord blood

Procedure

Drawing admission labs from infant blood

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Capt Alicia Prescott

Fed

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Apr 3, 2014
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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