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

Sponsor

Capt Alicia Prescott (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02103296

Collaborator

C.R.Darnall Army Medical Center (U.S. Fed), Walter Reed National Military Medical Center (U.S. Fed), United States Naval Medical Center, Portsmouth (U.S. Fed), Madigan Army Medical Center (U.S. Fed), Tripler Army Medical Center (U.S. Fed)

Enrollment

Locations

Arms

89.7

Duration (Months)

13.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Procedure: Drawing admission labs from cord blood Procedure: Drawing admission labs from infant blood	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Jul 25, 2021

Actual Study Completion Date :

Jul 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Infant Blood Control group. Admission labs to be drawn directly from the infant.	Procedure: Drawing admission labs from infant blood
Experimental: Cord Blood Admission labs to be drawn from the infant's cord blood	Procedure: Drawing admission labs from cord blood

Arm

Intervention/Treatment

Active Comparator: Infant Blood

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

Procedure: Drawing admission labs from infant blood

Experimental: Cord Blood

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

Procedure: Drawing admission labs from cord blood

Outcome Measures

Primary Outcome Measures

Absolute hemoglobin concentration [24 hours of life]
Percent change in hemoglobin concentration from baseline [24 hours of life]

Secondary Outcome Measures

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]
Head Ultrasound [Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Day

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
2	Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20889
3	Carl R. Darnall Army medical Center	Fort Hood	Texas	United States	78109
4	San Antonio Military Medical Center	Fort Sam Houston	Texas	United States	78234
5	Portsmouth Naval Medical Center	Portsmouth	Virginia	United States	23708
6	Madigan Army Medical Center	Tacoma	Washington	United States	98431

Sponsors and Collaborators

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

Investigators

Principal Investigator: Thornton S Mu, MD, San Antonio Military Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Capt Alicia Prescott, Associate Investogator, San Antonio Military Medical Center

ClinicalTrials.gov Identifier:

NCT02103296

Other Study ID Numbers:

393720-1

First Posted:

Apr 3, 2014

Last Update Posted:

Aug 20, 2021

Last Verified:

Aug 1, 2021

Additional relevant MeSH terms:

Birth Weight

Study Results

No Results Posted as of Aug 20, 2021