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

Capt Alicia Prescott6 sites in 1 country80 target enrollmentFebruary 2014

ConditionsAnemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anemia
Sponsor: Capt Alicia Prescott
Enrollment: 80
Locations: 6
Primary Endpoint: Absolute hemoglobin concentration
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

July 25, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Capt Alicia Prescott

Responsible Party

Sponsor Investigator

Principal Investigator

Capt Alicia Prescott

Associate Investogator

San Antonio Military Medical Center

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

Outcomes

Primary Outcomes

Absolute hemoglobin concentration

Time Frame: 24 hours of life

Percent change in hemoglobin concentration from baseline

Time Frame: 24 hours of life

Secondary Outcomes

Hemoglobin concentration at one week of life(one week)
Hemoglobin concentration at time of hospital discharge(Approximately 10 - 16 weeks)
Number of blood donor exposures(Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.)
Use of Vasopressors(Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.)
Number/volume of packed red blood cell (pRBC) transfusions(Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks)
Head Ultrasound(Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age)