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

NCT ID: NCT02103296

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2021-07-25

Brief Summary

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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

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Infant Blood

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

Group Type ACTIVE_COMPARATOR

Drawing admission labs from infant blood

Intervention Type PROCEDURE

Cord Blood

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

Group Type EXPERIMENTAL

Drawing admission labs from cord blood

Intervention Type PROCEDURE

Interventions

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Drawing admission labs from cord blood

Intervention Type PROCEDURE

Drawing admission labs from infant blood

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C.R.Darnall Army Medical Center

FED

Sponsor Role collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role collaborator

United States Naval Medical Center, Portsmouth

FED

Sponsor Role collaborator

Madigan Army Medical Center

FED

Sponsor Role collaborator

Tripler Army Medical Center

FED

Sponsor Role collaborator

Capt Alicia Prescott

FED

Sponsor Role lead

Responsible Party

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Capt Alicia Prescott

Associate Investogator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thornton S Mu, MD

Role: PRINCIPAL_INVESTIGATOR

San Antonio Military Medical Center

Locations

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Tripler Army Medical Center

Honolulu, Hawaii, United States

Site Status

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Carl R. Darnall Army medical Center

Fort Hood, Texas, United States

Site Status

San Antonio Military Medical Center

Fort Sam Houston, Texas, United States

Site Status

Portsmouth Naval Medical Center

Portsmouth, Virginia, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34407547 (View on PubMed)

Other Identifiers

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393720-1

Identifier Type: -

Identifier Source: org_study_id

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