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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02103296
Enrollment
80
Registered
2014-04-03
Start date
2014-02-28
Completion date
2021-07-25
Last updated
2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

PROCEDUREDrawing admission labs from cord blood
PROCEDUREDrawing admission labs from infant blood

Sponsors

C.R.Darnall Army Medical Center
CollaboratorFED
Walter Reed National Military Medical Center
CollaboratorFED
United States Naval Medical Center, Portsmouth
CollaboratorFED
Madigan Army Medical Center
CollaboratorFED
Tripler Army Medical Center
CollaboratorFED
Capt Alicia Prescott
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* No specific

Design outcomes

Primary

MeasureTime frame
Absolute hemoglobin concentration24 hours of life
Percent change in hemoglobin concentration from baseline24 hours of life

Secondary

MeasureTime frame
Use of VasopressorsParticipants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.
Hemoglobin concentration at one week of lifeone week
Number/volume of packed red blood cell (pRBC) transfusionsParticipants will be followed from birth until time of hospital discharge, an expected average of 13 weeks
Head UltrasoundRead at 7 Days of life and at hospital discharge which is approximately 13 weeks of age
Hemoglobin concentration at time of hospital dischargeApproximately 10 - 16 weeks
Number of blood donor exposuresParticipants will be followed from birth until time of hospital discharge, an expected average of 13 weeks.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026