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

Capt Alicia Prescott

Status: Completed

Conditions: Anemia

Treatments: Procedure: Drawing admission labs from cord blood; Procedure: Drawing admission labs from infant blood

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02103296

393720-1

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Infant Blood

Active Comparator group

Description:

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

Treatment:

Procedure: Drawing admission labs from infant blood

Cord Blood

Experimental group

Description:

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

Treatment:

Procedure: Drawing admission labs from cord blood