NCT02103296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

7.5 years

First QC Date

March 17, 2014

Last Update Submit

August 18, 2021

Conditions

Anemia

Outcome Measures

Primary Outcomes (2)

  • Absolute hemoglobin concentration

    24 hours of life

  • Percent change in hemoglobin concentration from baseline

    24 hours of life

Secondary Outcomes (6)

  • 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

  • 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.

  • Hemoglobin concentration at one week of life

    one week

  • Hemoglobin concentration at time of hospital discharge

    Approximately 10 - 16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Infant Blood

ACTIVE COMPARATOR

Control group. Admission labs to be drawn directly from the infant.

Procedure: Drawing admission labs from infant blood

Cord Blood

EXPERIMENTAL

Admission labs to be drawn from the infant's cord blood

Procedure: Drawing admission labs from cord blood

Interventions

Drawing admission labs from cord bloodPROCEDURE
Cord Blood
Drawing admission labs from infant bloodPROCEDURE
Infant Blood

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight less than 1200g or Gestational Age less than 30 weeks born at participating medical centers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Carl R. Darnall Army medical Center

Fort Hood, Texas, 78109, United States

Location

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Portsmouth Naval Medical Center

Portsmouth, Virginia, 23708, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (1)

  • Mu TS, Prescott AC, Haischer-Rollo GD, Aden JK, Shapiro JB. Umbilical Cord Blood Use for Admission Blood Tests of VLBW Preterm Neonates: A Randomized Control Trial. Am J Perinatol. 2023 Jul;40(10):1119-1125. doi: 10.1055/s-0041-1733781. Epub 2021 Aug 18.

    PMID: 34407547DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Thornton S Mu, MD

    San Antonio Military Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Investogator

Study Record Dates

First Submitted

March 17, 2014

First Posted

April 3, 2014

Study Start

February 1, 2014

Primary Completion

July 25, 2021

Study Completion

July 25, 2021

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

US(6)